Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-02-22 @ 9:37 AM
Study NCT ID:
NCT02266004
Status:
TERMINATED
Last Update Posted:
2020-06-30
First Post:
2014-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transcranial Direct Current Stimulation for Freezing of Gait
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cluca@med.miami.edu', 'phone': '305-243-6732', 'title': 'Corneliu Luca, MD', 'organization': 'University of Miami'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Data was not collected on 4 of the outcome measures due to lack of funding which contributed to the difficulty in performing the tests required per protocol.'}}, 'adverseEventsModule': {'timeFrame': '3 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 1, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'fall at home', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Walking Speed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.169', 'spread': '0.244', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 3 weeks', 'description': 'walking speed will be measured using sensors during a 90 second walk', 'unitOfMeasure': 'm/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Unable to retrieve collected data on the other 5 participants who completed the study due to a malfunction in the sensors.'}, {'type': 'SECONDARY', 'title': "Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.714', 'spread': '14.088', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 3 weeks', 'description': 'UPDRS motor score range from 0-56 with higher scores indicating greater impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Stride Length', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.127', 'spread': '0.239', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 3 weeks', 'description': "Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk.", 'unitOfMeasure': 'm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Unable to retrieve collected data on the other 5 participants who completed the study due to a malfunction in the sensors.'}, {'type': 'SECONDARY', 'title': 'Change in Postural Sway', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.012', 'spread': '0.009', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 3 weeks', 'description': "Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing.", 'unitOfMeasure': 'm^2/s^5', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Timed Up-and-Go (TUG) Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.878', 'spread': '4.268', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 3 weeks', 'description': 'Participants are timed while standing up from a chair, walking around a cone, and returning to their chair.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Motor Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.005', 'spread': '0.021', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 3 weeks', 'description': 'Transcranial magnetic stimulation is used to measure motor threshold of the primary motor area. The motor threshold was defined as the minimum intensity needed to evoke 5 out 10 motor evoked potentials in the first dorsal interosseous muscle in the hand.', 'unitOfMeasure': 'percentage of TMS output', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3-week data not collected for 5 participants who completed the study.'}, {'type': 'SECONDARY', 'title': 'Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.'}], 'timeFrame': 'baseline, 3 weeks', 'description': 'Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS).', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change in Backward Digit Span', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.'}], 'timeFrame': 'baseline, 3 weeks', 'description': 'Digit span is measured by total number of correct digits recited.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change in the Trail Making Test Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.'}], 'timeFrame': 'baseline, 3 weeks', 'description': 'Trail making test is measured as the number of seconds required to complete the task, with higher scores indicating greater impairment.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change in the Montreal Cognitive Assessment (MOCA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.57', 'spread': '1.89', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 3 weeks', 'description': 'The MOCA has a total score ranging from 0-30 with a higher score indicating better performance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in the Auditory Consonant Trigrams Test (ACT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.'}], 'timeFrame': 'baseline, 3 weeks', 'description': 'The ACT has a score from 0-60 with higher score indicating better performance.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data was collected for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change in the Freezing of Gait Questionnaire (FOG-Q)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.29', 'spread': '3.21', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, 3 weeks', 'description': 'The FOG-Q has a total score ranging from 0-24 with higher scores indicating more incidents of freezing.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'unrelated adverse event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'One participant was removed from the study and re-enrolled. However, this participant did not complete the study intervention on their first or second enrollment. Therefore their data has not been included in any of the outcome measures.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.\n\nTranscranial Direct Current Stimulation (tDCS): Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.\n\nlocomotor training: An individualized dual-task walking program for approximately 30 minutes.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.4', 'spread': '9.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-02', 'size': 1404296, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-05-26T14:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'difficult to recruit participants', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-16', 'studyFirstSubmitDate': '2014-10-07', 'resultsFirstSubmitDate': '2020-05-28', 'studyFirstSubmitQcDate': '2014-10-10', 'lastUpdatePostDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-28', 'studyFirstPostDateStruct': {'date': '2014-10-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Walking Speed', 'timeFrame': 'baseline, 3 weeks', 'description': 'walking speed will be measured using sensors during a 90 second walk'}], 'secondaryOutcomes': [{'measure': "Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS)", 'timeFrame': 'baseline, 3 weeks', 'description': 'UPDRS motor score range from 0-56 with higher scores indicating greater impairment.'}, {'measure': 'Change in Stride Length', 'timeFrame': 'baseline, 3 weeks', 'description': "Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk."}, {'measure': 'Change in Postural Sway', 'timeFrame': 'baseline, 3 weeks', 'description': "Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing."}, {'measure': 'Change in Timed Up-and-Go (TUG) Time', 'timeFrame': 'baseline, 3 weeks', 'description': 'Participants are timed while standing up from a chair, walking around a cone, and returning to their chair.'}, {'measure': 'Change in Motor Threshold', 'timeFrame': 'baseline, 3 weeks', 'description': 'Transcranial magnetic stimulation is used to measure motor threshold of the primary motor area. The motor threshold was defined as the minimum intensity needed to evoke 5 out 10 motor evoked potentials in the first dorsal interosseous muscle in the hand.'}, {'measure': 'Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio', 'timeFrame': 'baseline, 3 weeks', 'description': 'Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS).'}, {'measure': 'Change in Backward Digit Span', 'timeFrame': 'baseline, 3 weeks', 'description': 'Digit span is measured by total number of correct digits recited.'}, {'measure': 'Change in the Trail Making Test Time', 'timeFrame': 'baseline, 3 weeks', 'description': 'Trail making test is measured as the number of seconds required to complete the task, with higher scores indicating greater impairment.'}, {'measure': 'Change in the Montreal Cognitive Assessment (MOCA)', 'timeFrame': 'baseline, 3 weeks', 'description': 'The MOCA has a total score ranging from 0-30 with a higher score indicating better performance.'}, {'measure': 'Change in the Auditory Consonant Trigrams Test (ACT)', 'timeFrame': 'baseline, 3 weeks', 'description': 'The ACT has a score from 0-60 with higher score indicating better performance.'}, {'measure': 'Change in the Freezing of Gait Questionnaire (FOG-Q)', 'timeFrame': 'baseline, 3 weeks', 'description': 'The FOG-Q has a total score ranging from 0-24 with higher scores indicating more incidents of freezing.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['transcranial direct current stimulation', 'neuromodulation'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "This study will evaluate the effects of transcranial direct current stimulation (tDCS) in combination with locomotor training in patients with Parkinson's disease (PD) and freezing of gait (FOG)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. age 18- 80\n2. Parkinson's disease stages 2-3 Hoehn and Yahr.\n3. Presence of Freezing of Gait\n4. Stable medication regimen\n5. Time to complete TUG \\>12 seconds\n\nExclusion Criteria:\n\n1. medical condition that would interfere with walking and training for 30 minutes\n2. unable to perform timed up and go in the off condition\n3. history of seizures\n4. implanted deep brain stimulator, pacemaker or any other electronic device.\n5. dementia\n6. Adults unable to consent, individuals who are not yet adults (infants, children, teenagers) pregnant women, prisoners will not be considered for participation"}, 'identificationModule': {'nctId': 'NCT02266004', 'acronym': 'TDCS-FOG', 'briefTitle': 'Transcranial Direct Current Stimulation for Freezing of Gait', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': "Transcranial Direct Current Stimulation for Freezing of Gait in Patients With Parkinson's Disease", 'orgStudyIdInfo': {'id': '20140127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'tDCS+ LT', 'description': 'Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.', 'interventionNames': ['Device: Transcranial Direct Current Stimulation (tDCS)', 'Other: locomotor training']}], 'interventions': [{'name': 'Transcranial Direct Current Stimulation (tDCS)', 'type': 'DEVICE', 'otherNames': ['tDCS'], 'description': 'Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.', 'armGroupLabels': ['tDCS+ LT']}, {'name': 'locomotor training', 'type': 'OTHER', 'description': 'An individualized dual-task walking program for approximately 30 minutes.', 'armGroupLabels': ['tDCS+ LT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}], 'overallOfficials': [{'name': 'Corneliu Luca, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant Professor of Neurology', 'investigatorFullName': 'Corneliu C Luca', 'investigatorAffiliation': 'University of Miami'}}}}