Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-02-24 @ 11:01 AM
Study NCT ID:
NCT02549859
Status:
COMPLETED
Last Update Posted:
2020-10-29
First Post:
2015-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D046690', 'term': 'Deep Brain Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lani@neurology.bsd.uchicago.edu', 'phone': '7738341688', 'title': 'Ms. Lani Leong, Research Coordinator', 'organization': 'University of Chicago'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'It is only tested on PD patients with FOG refractory to the 130Hz of bilateral STN DBS at usual medication "on" state, with limited participants.'}}, 'adverseEventsModule': {'timeFrame': "Data on adverse events were collected beginning from the time of consent and extending until all study procedures were complete for the patient, an average of 14.5 months. After patient's second visit was completed, no further AEs were collected.", 'description': 'AE and SAE were defined by the investigator as any medical event that the patient and doctor considered medically relevant.', 'eventGroups': [{'id': 'EG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '1.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'A speech pathologist used the Penetration-Aspiration Scale (PAS) to rate swallows captured by a radiologist during VFSS recording. PAS is an 8-point interval scale: a score of 0 indicates no penetration or aspiration \\& a score of 6-8 indicates aspiration of increasing severity. For the purpose of this study, aspiration was dichotomized to "0" if PAS score was under 6 or "1" if PAS score was between 6-8. Frequency of aspiration events was calculated by adding number of aspiration events in VFSS under various liquid \\& food textures. The maximum aspiration frequency was 12 if aspiration occurred on every texture after 2 trials. Lower aspiration frequency means better swallowing function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 1'}, {'type': 'PRIMARY', 'title': 'Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '3.1', 'spread': '1.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'The Swallowing Disturbance Questionnaire contains 15 items. Each item has 4-points ranging from 0 (absence of symptoms) to 3 (severe or very frequent). Total score ranges from 0-45, with higher scores corresponding to more severe swallowing disturbance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 1'}, {'type': 'PRIMARY', 'title': 'Freezing of Gait Questionnaire at Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '9.3', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '5.1', 'spread': '3.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The Freezing of Gait (FOG) Questionnaire contains 6 items to evaluate the severity of FOG in patients with Parkinson's disease. Each item has 5 points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-24, with higher scores corresponding to more severe FOG.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 1'}, {'type': 'PRIMARY', 'title': 'Stand-Walk-Sit Freezing of Gait Spells at Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '1.6', 'spread': '1.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'The Stand-Walk-Sit (SWS) Test assesses freezing of gait (FOG) spells observed when standing up, walking 7 meters, and returning to a seated position. The greater the number of FOG spells counted, the worse the FOG symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 1'}, {'type': 'PRIMARY', 'title': 'Stand-Walk-Sit Time at Visit 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'spread': '7.1', 'groupId': 'OG000'}, {'value': '28.5', 'spread': '8.5', 'groupId': 'OG001'}, {'value': '23.6', 'spread': '6.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'Stand-Walk-Sit (SWS) Time measures the total time taken to complete the SWS test of standing up, walking 7 meters, and returning to a sitting position. The longer time (in seconds) it took to complete the SWS test, the worse the FOG symptoms.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 1'}, {'type': 'PRIMARY', 'title': 'Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '2.4', 'spread': '2.6', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'A speech pathologist used the Penetration-Aspiration Scale (PAS) to rate swallows captured by a radiologist during VFSS recording. PAS is an 8-point interval scale: a score of 0 indicates no penetration or aspiration \\& a score of 6-8 indicates aspiration of increasing severity. For the purpose of this study, aspiration was dichotomized to "0" if PAS score was under 6 or "1" if PAS score was between 6-8. Frequency of aspiration events was calculated by adding number of aspiration events in VFSS under various liquid \\& food textures. The maximum aspiration frequency was 12 if aspiration occurred on every texture after 2 trials. Lower aspiration frequency means better swallowing function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 2'}, {'type': 'PRIMARY', 'title': 'Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '5.7', 'spread': '6.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'The Swallowing Disturbance Questionnaire contains 15 items. Each item has 4-points ranging from 0 (absence of symptoms) to 3 (severe or very frequent). Total score ranges from 0-45, with higher scores corresponding to more severe swallowing disturbance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 2'}, {'type': 'PRIMARY', 'title': 'Freezing of Gait Questionnaire at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '4.1', 'groupId': 'OG001'}, {'value': '7.0', 'spread': '4.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The Freezing of Gait (FOG) Questionnaire contains 6 items to evaluate the severity of FOG in patients with Parkinson's disease. Each item has 5 points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-24, with higher scores corresponding to more severe FOG.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 2'}, {'type': 'PRIMARY', 'title': 'Stand-Walk-Sit Freezing of Gait Spells at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '7.0', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '2.8', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'The Stand-Walk-Sit (SWS) Test assesses freezing of gait (FOG) spells observed when standing up, walking 7 meters, and returning to a seated position. The greater the number of FOG spells counted, the worse the FOG symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 2'}, {'type': 'PRIMARY', 'title': 'Stand-Walk-Sit Time at Visit 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '12.2', 'groupId': 'OG000'}, {'value': '38.4', 'spread': '26.0', 'groupId': 'OG001'}, {'value': '27.8', 'spread': '11.9', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'Stand-Walk-Sit (SWS) Time measures the total time taken to complete the SWS test of standing up, walking 7 meters, and returning to a sitting position. The longer time (in seconds) it took to complete the SWS test, the worse the FOG symptoms.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 2'}, {'type': 'SECONDARY', 'title': "Unified Parkinson's Disease Rating Scale-III Total Score at Visit 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.8', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '33.7', 'spread': '8.3', 'groupId': 'OG001'}, {'value': '34.4', 'spread': '12.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 33 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-132, with higher scores corresponding to more severe parkinsonism.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 1'}, {'type': 'SECONDARY', 'title': "Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '6.9', 'spread': '4.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The axial subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 7 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-28, with higher scores corresponding to more severe axial symptoms. Specifically, axial symptoms include: speech, facial expression, arising from chair, gait, freezing of gait, postural stability, posture.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 1'}, {'type': 'SECONDARY', 'title': "Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '4.6', 'groupId': 'OG001'}, {'value': '17.1', 'spread': '5.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The bradykinesia subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 11 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-44, with higher scores corresponding to more severe bradykinesia. Specifically, bradykinesia symptoms include: finger tapping right hand, finger tapping left hand, hand movements right hand, hand movements left hand, pronation-supination movements right hand, pronation- supination movements left hand, toe tapping right foot, toe tapping left foot, leg agility right leg, leg agility left leg, global spontaneity of movement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 1'}, {'type': 'SECONDARY', 'title': "Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '4.9', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '6.0', 'spread': '3.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The rigidity subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 5 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-20. with higher scores corresponding to more severe rigidity. Specifically, rigidity symptoms include: rigidity neck, rigidity right upper extremity, rigidity left upper extremity, rigidity right lower extremity, rigidity left lower extremity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 1'}, {'type': 'SECONDARY', 'title': "Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '2.5', 'spread': '3.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The tremor subscore of Unified Parkinson's Disease Rating Scale (UPDRS-III) contains 10 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-40, with higher scores corresponding to more severe tremor. Specifically, tremor symptoms include: postural tremor right hand, postural tremor left hand, kinetic tremor right hand, kinetic tremor left hand, rest tremor amplitude right upper extremity, rest tremor amplitude left upper extremity, rest tremor amplitude right lower extremity, rest tremor amplitude left lower extremity, rest tremor amplitude lip/jaw, constancy of rest tremor.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 1'}, {'type': 'SECONDARY', 'title': "Unified Parkinson's Disease Rating Scale-III Total Score at Visit 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.1', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '32.4', 'spread': '7.1', 'groupId': 'OG001'}, {'value': '31.4', 'spread': '10.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 33 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-132, with higher scores corresponding to more severe parkinsonism.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 2'}, {'type': 'SECONDARY', 'title': "Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '3.9', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '4.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The axial subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 7 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-28, with higher scores corresponding to more severe axial symptoms. Specifically, axial symptoms include: speech, facial expression, arising from chair, gait, freezing of gait, postural stability, posture.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 2'}, {'type': 'SECONDARY', 'title': "Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '16.3', 'spread': '2.3', 'groupId': 'OG001'}, {'value': '15.7', 'spread': '3.7', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The bradykinesia subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 11 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-44, with higher scores corresponding to more severe bradykinesia. Specifically, bradykinesia symptoms include: finger tapping right hand, finger tapping left hand, hand movements right hand, hand movements left hand, pronation-supination movements right hand, pronation- supination movements left hand, toe tapping right foot, toe tapping left foot, leg agility right leg, leg agility left leg, global spontaneity of movement.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 2'}, {'type': 'SECONDARY', 'title': "Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.1', 'groupId': 'OG001'}, {'value': '4.8', 'spread': '2.4', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The rigidity subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 5 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-20. with higher scores corresponding to more severe rigidity. Specifically, rigidity symptoms include: rigidity neck, rigidity right upper extremity, rigidity left upper extremity, rigidity right lower extremity, rigidity left lower extremity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 2'}, {'type': 'SECONDARY', 'title': "Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2", 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'DBS 60Hz', 'description': 'Participants were on DBS 60Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG001', 'title': 'DBS 130Hz', 'description': 'Participants were on DBS 130Hz for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}, {'id': 'OG002', 'title': 'DBS Off', 'description': 'Participants were on DBS off for at least 30 min before evaluation. The order of administration of DBS conditions was randomized, and the participants and study team were blinded to the DBS condition.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.6', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '1.2', 'spread': '2.0', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Paired t-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The tremor subscore of Unified Parkinson's Disease Rating Scale (UPDRS-III) contains 10 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-40, with higher scores corresponding to more severe tremor. Specifically, tremor symptoms include: postural tremor right hand, postural tremor left hand, kinetic tremor right hand, kinetic tremor left hand, rest tremor amplitude right upper extremity, rest tremor amplitude left upper extremity, rest tremor amplitude right lower extremity, rest tremor amplitude left lower extremity, rest tremor amplitude lip/jaw, constancy of rest tremor.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants completing Visit 2'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Deep Brain Stimulation (DBS)', 'description': 'All patients were treated and assessed under three conditions (60 Hz DBS, 130 Hz DBS and no DBS) at Visit 1 (V1), were then treated with 60 Hz DBS for at least 6 months (14.5 months on average), and were finally reassessed during a second visit (V2) under the same three conditions as V1. The order of treatment/assessment under the three conditions was randomized at each visit.'}], 'periods': [{'title': 'Visit 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Long-term 60 Hz DBS', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study Closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}, {'title': 'Visit 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '15 patients were screened for eligibility at a hospital-associated specialty clinic in Chicago, IL.', 'preAssignmentDetails': 'Eleven of 15 screened participants were enrolled; four did not meet inclusion/exclusion criteria. Five of the enrolled participants had participated in a previous study and had been treated on 60Hz DBS since then; their Visit 1 (V1) measurements were taken from the previous study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Deep Brain Stimulation (DBS)', 'description': 'All patients were treated and assessed under three conditions (60 Hz DBS, 130 Hz DBS and no DBS) at Visit 1 (V1), were then treated with 60 Hz DBS for at least 6 months (14.5 months on average), and were finally reassessed during a second visit (V2) under the same three conditions as V1. The order of treatment/assessment under the three conditions was randomized at each visit.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White, non-Hispanic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': "Parkinson's Disease Duration", 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '5.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'DBS at High Frequency Stimulation Duration', 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '4.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-07-01', 'size': 196222, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-07T18:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2015-08-31', 'resultsFirstSubmitDate': '2020-05-28', 'studyFirstSubmitQcDate': '2015-09-11', 'lastUpdatePostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-08', 'studyFirstPostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 1', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'A speech pathologist used the Penetration-Aspiration Scale (PAS) to rate swallows captured by a radiologist during VFSS recording. PAS is an 8-point interval scale: a score of 0 indicates no penetration or aspiration \\& a score of 6-8 indicates aspiration of increasing severity. For the purpose of this study, aspiration was dichotomized to "0" if PAS score was under 6 or "1" if PAS score was between 6-8. Frequency of aspiration events was calculated by adding number of aspiration events in VFSS under various liquid \\& food textures. The maximum aspiration frequency was 12 if aspiration occurred on every texture after 2 trials. Lower aspiration frequency means better swallowing function.'}, {'measure': 'Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 1', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'The Swallowing Disturbance Questionnaire contains 15 items. Each item has 4-points ranging from 0 (absence of symptoms) to 3 (severe or very frequent). Total score ranges from 0-45, with higher scores corresponding to more severe swallowing disturbance.'}, {'measure': 'Freezing of Gait Questionnaire at Visit 1', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The Freezing of Gait (FOG) Questionnaire contains 6 items to evaluate the severity of FOG in patients with Parkinson's disease. Each item has 5 points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-24, with higher scores corresponding to more severe FOG."}, {'measure': 'Stand-Walk-Sit Freezing of Gait Spells at Visit 1', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'The Stand-Walk-Sit (SWS) Test assesses freezing of gait (FOG) spells observed when standing up, walking 7 meters, and returning to a seated position. The greater the number of FOG spells counted, the worse the FOG symptoms.'}, {'measure': 'Stand-Walk-Sit Time at Visit 1', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'Stand-Walk-Sit (SWS) Time measures the total time taken to complete the SWS test of standing up, walking 7 meters, and returning to a sitting position. The longer time (in seconds) it took to complete the SWS test, the worse the FOG symptoms.'}, {'measure': 'Frequency of Aspiration Events on Videofluoroscopic Swallow Study at Visit 2', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'A speech pathologist used the Penetration-Aspiration Scale (PAS) to rate swallows captured by a radiologist during VFSS recording. PAS is an 8-point interval scale: a score of 0 indicates no penetration or aspiration \\& a score of 6-8 indicates aspiration of increasing severity. For the purpose of this study, aspiration was dichotomized to "0" if PAS score was under 6 or "1" if PAS score was between 6-8. Frequency of aspiration events was calculated by adding number of aspiration events in VFSS under various liquid \\& food textures. The maximum aspiration frequency was 12 if aspiration occurred on every texture after 2 trials. Lower aspiration frequency means better swallowing function.'}, {'measure': 'Perceived Swallowing Difficulty on Swallowing Disturbance Questionnaire at Visit 2', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'The Swallowing Disturbance Questionnaire contains 15 items. Each item has 4-points ranging from 0 (absence of symptoms) to 3 (severe or very frequent). Total score ranges from 0-45, with higher scores corresponding to more severe swallowing disturbance.'}, {'measure': 'Freezing of Gait Questionnaire at Visit 2', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The Freezing of Gait (FOG) Questionnaire contains 6 items to evaluate the severity of FOG in patients with Parkinson's disease. Each item has 5 points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-24, with higher scores corresponding to more severe FOG."}, {'measure': 'Stand-Walk-Sit Freezing of Gait Spells at Visit 2', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'The Stand-Walk-Sit (SWS) Test assesses freezing of gait (FOG) spells observed when standing up, walking 7 meters, and returning to a seated position. The greater the number of FOG spells counted, the worse the FOG symptoms.'}, {'measure': 'Stand-Walk-Sit Time at Visit 2', 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': 'Stand-Walk-Sit (SWS) Time measures the total time taken to complete the SWS test of standing up, walking 7 meters, and returning to a sitting position. The longer time (in seconds) it took to complete the SWS test, the worse the FOG symptoms.'}], 'secondaryOutcomes': [{'measure': "Unified Parkinson's Disease Rating Scale-III Total Score at Visit 1", 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 33 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-132, with higher scores corresponding to more severe parkinsonism."}, {'measure': "Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1", 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The axial subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 7 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-28, with higher scores corresponding to more severe axial symptoms. Specifically, axial symptoms include: speech, facial expression, arising from chair, gait, freezing of gait, postural stability, posture."}, {'measure': "Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1", 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The bradykinesia subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 11 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-44, with higher scores corresponding to more severe bradykinesia. Specifically, bradykinesia symptoms include: finger tapping right hand, finger tapping left hand, hand movements right hand, hand movements left hand, pronation-supination movements right hand, pronation- supination movements left hand, toe tapping right foot, toe tapping left foot, leg agility right leg, leg agility left leg, global spontaneity of movement."}, {'measure': "Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1", 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The rigidity subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 5 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-20. with higher scores corresponding to more severe rigidity. Specifically, rigidity symptoms include: rigidity neck, rigidity right upper extremity, rigidity left upper extremity, rigidity right lower extremity, rigidity left lower extremity."}, {'measure': "Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 1", 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The tremor subscore of Unified Parkinson's Disease Rating Scale (UPDRS-III) contains 10 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-40, with higher scores corresponding to more severe tremor. Specifically, tremor symptoms include: postural tremor right hand, postural tremor left hand, kinetic tremor right hand, kinetic tremor left hand, rest tremor amplitude right upper extremity, rest tremor amplitude left upper extremity, rest tremor amplitude right lower extremity, rest tremor amplitude left lower extremity, rest tremor amplitude lip/jaw, constancy of rest tremor."}, {'measure': "Unified Parkinson's Disease Rating Scale-III Total Score at Visit 2", 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 33 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-132, with higher scores corresponding to more severe parkinsonism."}, {'measure': "Axial Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2", 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The axial subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 7 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-28, with higher scores corresponding to more severe axial symptoms. Specifically, axial symptoms include: speech, facial expression, arising from chair, gait, freezing of gait, postural stability, posture."}, {'measure': "Bradykinesia Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2", 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The bradykinesia subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 11 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-44, with higher scores corresponding to more severe bradykinesia. Specifically, bradykinesia symptoms include: finger tapping right hand, finger tapping left hand, hand movements right hand, hand movements left hand, pronation-supination movements right hand, pronation- supination movements left hand, toe tapping right foot, toe tapping left foot, leg agility right leg, leg agility left leg, global spontaneity of movement."}, {'measure': "Rigidity Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2", 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The rigidity subscore of Unified Parkinson's Disease Rating Scale-III (UPDRS-III) contains 5 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-20. with higher scores corresponding to more severe rigidity. Specifically, rigidity symptoms include: rigidity neck, rigidity right upper extremity, rigidity left upper extremity, rigidity right lower extremity, rigidity left lower extremity."}, {'measure': "Tremor Subscore of Unified Parkinson's Disease Rating Scale-III at Visit 2", 'timeFrame': 'Immediately following treatment for at least 30 minutes', 'description': "The tremor subscore of Unified Parkinson's Disease Rating Scale (UPDRS-III) contains 10 items. Each item has 5-points ranging from 0 (absence of symptoms) to 4 (severe). Total score ranges from 0-40, with higher scores corresponding to more severe tremor. Specifically, tremor symptoms include: postural tremor right hand, postural tremor left hand, kinetic tremor right hand, kinetic tremor left hand, rest tremor amplitude right upper extremity, rest tremor amplitude left upper extremity, rest tremor amplitude right lower extremity, rest tremor amplitude left lower extremity, rest tremor amplitude lip/jaw, constancy of rest tremor."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DBS', 'Low frequency stimulation', 'Dysphagia', 'Freezing of gait'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'references': [{'pmid': '25540305', 'type': 'RESULT', 'citation': 'Xie T, Vigil J, MacCracken E, Gasparaitis A, Young J, Kang W, Bernard J, Warnke P, Kang UJ. Low-frequency stimulation of STN-DBS reduces aspiration and freezing of gait in patients with PD. Neurology. 2015 Jan 27;84(4):415-20. doi: 10.1212/WNL.0000000000001184. Epub 2014 Dec 24.'}, {'pmid': '29654112', 'type': 'RESULT', 'citation': 'Xie T, Bloom L, Padmanaban M, Bertacchi B, Kang W, MacCracken E, Dachman A, Vigil J, Satzer D, Zadikoff C, Markopoulou K, Warnke P, Kang UJ. Long-term effect of low frequency stimulation of STN on dysphagia, freezing of gait and other motor symptoms in PD. J Neurol Neurosurg Psychiatry. 2018 Sep;89(9):989-994. doi: 10.1136/jnnp-2018-318060. Epub 2018 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'Our recent study (Xie et al, Neurology 2015; 84: 415-420) found that bilateral STN DBS of 60Hz, compared to the traditional 130Hz, decreased the aspiration frequency and swallowing difficulty, freezing of gait (FOG), and other axial symptoms and parkinsonism in Parkinson patients with FOG refractory to 130Hz and medications. The benefit of 60Hz stimulation persisted during the 6-week study period, but with worsening tremor in one patient. However, it remains unknown whether the benefit of 60Hz would persist on prolonged stimulation period, and whether there is carry-over effect across different conditions. Hence, the investigators would like to test the hypothesis that the 60Hz stimulation, compared to 130Hz might have persistent benefit over an extended period in reducing the swallowing dysfunction, FOG, and other axial symptoms in these PD patients even after correcting the potential carry-over effect.', 'detailedDescription': 'The investigators will enroll 14 Parkinson patients with bilateral STN DBS and refractory FOG to 130Hz stimulation and dopaminergic medications for two visits of at least 6-month apart. The 6 patients remaining on 60Hz stimulation after our previous study consisting of 7 patients will be assessed once again as visit-2 after previous visit-1 of their last study. We anticipate to have 20 patents complete for visit-1 and at least 18 patients complete for visit-2 in this randomized double-blind prospective crossover study with their usual medication "on" state, with 6-7 patients on each starting condition (60Hz vs 130Hz vs DBS off). Swallowing function on modified barium swallowing test and swallowing questionnaire, FOG in stand-walk-sit test and questionnaire, and other axial and motor function on UPDRS-III will be assessed under each DBS condition. Changes in measurements between 60Hz and 130Hz at each visit and under 60Hz between two visits will be analyzed, with swallowing function and FOG as primary, and the rest as secondary outcomes, correcting for potential carryover effect. Changes between other DBS conditions might also be explored in this 2-year study.\n\nThis would be the first study on the long-term effect of 60Hz stimulation on dysphagia, FOG and other axial and motor symptoms in Parkinson patients with bilateral STN DBS and FOG refractory to 130Hz stimulation and dopaminergic medications, which will have significant impact on the treatment of difficult axial symptoms of high morbidity and mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* PD patients with bilateral STN DBS placement and FOG at 130Hz even at usual medication "on" state.\n\nExclusion Criteria:\n\n* Known history of recent aspiration pneumonia'}, 'identificationModule': {'nctId': 'NCT02549859', 'briefTitle': 'Long-term Effect of Low Frequency Stimulation on Aspiration and Freezing of Gait in PD With STN DBS', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'Long-term Effect of Low Frequency 60Hz Stimulation on Aspiration, Freezing of Gait and Other Axial and Motor Symptoms in PD Patients With Bilateral STN DBS', 'orgStudyIdInfo': {'id': 'IRB 15-0539'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deep Brain Stimulation (DBS)', 'description': 'All patients were treated and assessed under three conditions (60 Hz DBS, 130 Hz DBS and no DBS) at Visit 1 (V1), were then treated with 60 Hz DBS for at least 6 months (14.5 months on average), and were finally reassessed during a second visit (V2) under the same three conditions as V1. The order of treatment/assessment under the three conditions was randomized at each visit.', 'interventionNames': ['Device: Deep Brain Stimulation (DBS) at 60 Hz', 'Device: Deep Brain Stimulation (DBS) at 130 Hz', 'Device: Deep Brain Stimulation (DBS) Off (Sham)']}], 'interventions': [{'name': 'Deep Brain Stimulation (DBS) at 60 Hz', 'type': 'DEVICE', 'otherNames': ['Low Frequency Stimulation (LFS)'], 'description': 'Bilateral subthalamic nucleus deep brain stimulation at 60 Hz', 'armGroupLabels': ['Deep Brain Stimulation (DBS)']}, {'name': 'Deep Brain Stimulation (DBS) at 130 Hz', 'type': 'DEVICE', 'otherNames': ['High Frequency Stimulation (HFS)'], 'description': 'Bilateral subthalamic nucleus deep brain stimulation at 130 Hz', 'armGroupLabels': ['Deep Brain Stimulation (DBS)']}, {'name': 'Deep Brain Stimulation (DBS) Off (Sham)', 'type': 'DEVICE', 'description': 'Deep Brain Stimulation (DBS) Off (Sham)', 'armGroupLabels': ['Deep Brain Stimulation (DBS)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago, Department of Neurology', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Tao Xie, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': "Michael J. Fox Foundation for Parkinson's Research", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}