Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT06316232
Status:
RECRUITING
Last Update Posted:
2024-03-18
First Post:
2024-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D051346', 'term': 'Mobility Limitation'}], '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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The count and duration of FoG episodes during the standardize walking protocol is measured on video-assessment by two blind raters.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'In addition to baseline gait assessment performed in a morning session on MED ON/STIM ON condition (after usual levodopa morning dose and usual parameters of stimulation), patients are evaluated in two following morning sessions under different treatment conditions:\n\n1. STIM ON plus: evaluation after the administration of levodopa morning dose and the increase of intensity of stimulation of 0.5 mA bilaterally,\n2. MED ON plus: evaluation after the administration of a 2x levodopa morning dose with usual parameters of stimulation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2024-03-01', 'studyFirstSubmitQcDate': '2024-03-11', 'lastUpdatePostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time spent with FOG during protocol', 'timeFrame': 'immediate post monitoring', 'description': 'Video-assessed reduction in the total time of FoG during the standardize walking protocol in MED ON plus or STIM ON plus condition compared to baseline.'}], 'secondaryOutcomes': [{'measure': 'Gait performance', 'timeFrame': 'immediate post monitoring', 'description': 'Changes in gait parameters measured by a system of 3 wearable inertial sensors, including: gait speed, stride lenght, number of step, cadence, gait variability, left-right asymmetry during MED ON plus or STIM ON plus protocol compared to baseline.'}, {'measure': "MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III", 'timeFrame': 'immediate post monitoring', 'description': 'Change in items 3.10 and 3.11 MDS UPDRS part III and total score between MED ON plus or STIM ON plus condition and baseline.'}, {'measure': 'Patient global impression of change (PGI-C)', 'timeFrame': 'immediate post monitoring', 'description': 'Change in PGI-C scores on MED ON plus or STIM ON plus condition compared to baseline.'}, {'measure': 'Trail Making test A and B', 'timeFrame': 'immediate post monitoring', 'description': 'Change in Trail Making test A and B scores during MED ON plus or STIM ON plus protocol compared to baseline.'}, {'measure': 'Phonemic/Semantic alternate Fluency test', 'timeFrame': 'immediate post monitoring', 'description': 'Change in during Phonemic/Semantic alternate Fluency test scores between MED ON plus or STIM ON plus condition and baseline.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['freezing of gait', 'gait disturbances', 'parkinson disease'], 'conditions': ['Freezing of Gait', 'Parkinson Disease']}, 'descriptionModule': {'briefSummary': "Freezing of gait (FoG) is a complex symptom of Parkinson's disease (PD) that cause falls and disability in PD patients, heavily affect patients' autonomy and quality of life. Gait disturbances and FoG are difficult to manage as they usually do not complete respond to both dopaminergic treatment and subthalamic nucleus deep brain stimulation (STN-DBS). One therapeutic strategy suggested in literature for improving gait disturbances is to increase the dose of dopaminergic drugs according to the hypothesis of pseudo-ON-freezing. The pseudo-ON-FoG in patients treated with STN-DBS can easily occur as the result of a suboptimal stimulation or the consequence of a post-operative reduction of the dopaminergic therapy. Therefore, it is reasonable hypothesize both the increase of stimulation and levodopa as good therapeutic strategies to improve pseudo-ON-FoG. At present there are no evidence for suppose that one option is better than the other, even though two recent studies on gait analysis reported a positive additive effect of levodopa therapy on gait parameters in patients treated with STN-DBS.\n\nIn this study, the investigators aim to objectively evaluating the improvement of FoG in PD patients treated with STN-DBS at different treatment conditions consisting of increased intensity of stimulation or higher dosage of levodopa.", 'detailedDescription': "This is a cross-over, blind, randomized study to evaluate the improvement of FoG in a group of PD patients treated with bilateral STN-DBS by increasing the intensity of stimulation (STIM plus) or administering a higher dose of levodopa (MED plus).\n\nPatient will be videorecorded for evaluation of freezing episodes and gait cinematic parameters by means of 3 wearable inertial sensors on the feet and at lumbar level during a standardized walking protocol including: Timed Up and Go, Turn 360°, Gait 18 m and a Complex task in single task and dual task (serial-3 subtractions) conditions. In each condition, Tinetti scale, Trail Making Test, alternate fluency test, Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS) and MDS Unified Dyskinesia Rating Scale (UDysRS) will be also perform.\n\nIn addition, other demographic and clinical information such as age, sex, MMSE, MoCA, New Freezing of Gait Questionnaire, Falls Efficacy Scale will be collected.\n\nThe primary endpoint of this study is to investigate the efficacy of increasing intensity of stimulation (STIM plus) or levodopa (MED plus) on freezing of gait (FOG).\n\nSecondary outcome measures include cinematic gait parameters, global motor outcomes and cognitive functions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with Parkinson's disease treated with STN-DBS who achieved a good control of motor fluctuations and cardinal motor symptoms (bradykinesia, rigidity, tremor)\n* History of FoG in daily-ON condition after optimal DBS programming, defined by a score of 1 on Question 1 and score ≥ 2 on Question 2 of the New Freezing of Gait Questionnaire.\n\nExclusion Criteria:\n\n* inability to walk independently for 10 meters.\n* limited therapeutic windows of stimulation without the possibility of increase the intensity of stimulation of 0,5 mA for the appearance of side effects\n* previous evidence of severe adverse effects with high levodopa dose ore increased STN-DBS intensity, such as psychosis, hallucinations, painful dyskinesias, severe hypotension, digestive symptoms.\n* dementia (MMSE score ≤ 18)"}, 'identificationModule': {'nctId': 'NCT06316232', 'briefTitle': "DBS and Levodopa for Treating Freezing of Gait in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Istituto delle Scienze Neurologiche di Bologna'}, 'officialTitle': "Efficacy of Deep Brain Stimulation and Levodopa on Freezing of Gait in Advanced Parkinson's Disease: a Comparative Study", 'orgStudyIdInfo': {'id': 'DBS-FOG 2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'STIM ON plus/MED ON plus', 'description': 'Patients were evaluated in two following morning sessions under different treatment conditions:\n\n1. STIM ON plus (intervention 1)\n2. MED ON plus (intervention 2)', 'interventionNames': ['Device: STIM ON plus', 'Drug: MED ON plus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MED ON plus/STIM ON plus', 'description': 'Patients were evaluated in two following morning sessions under different treatment conditions:\n\n1. MED ON plus (intervention 2)\n2. STIM ON plus (intervention 1)', 'interventionNames': ['Device: STIM ON plus', 'Drug: MED ON plus']}], 'interventions': [{'name': 'STIM ON plus', 'type': 'DEVICE', 'description': 'increase of intensity of stimulation of 0.5 mA bilaterally', 'armGroupLabels': ['MED ON plus/STIM ON plus', 'STIM ON plus/MED ON plus']}, {'name': 'MED ON plus', 'type': 'DRUG', 'description': 'administration of a 2x levodopa morning dose', 'armGroupLabels': ['MED ON plus/STIM ON plus', 'STIM ON plus/MED ON plus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40139', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Ilaria Cani', 'role': 'CONTACT', 'email': 'ilaria.cani@studio.unibo.it', 'phone': '0039 051 4966959'}, {'name': 'Giulia Giannini', 'role': 'CONTACT', 'email': 'giulia.giannini15@unibo.it', 'phone': '0039 051 4966959'}, {'name': 'Giovanna Calandra Buonaura, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ilaria Cani, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carlo Alberto Artusi, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Giulia Giannini, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Istituto delle Scienze Neurologiche di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Ilaria Cani', 'role': 'CONTACT', 'email': 'ilaria.cani@studio.unibo.it', 'phone': '0039 051 4966959'}, {'name': 'Giulia Giannini', 'role': 'CONTACT', 'email': 'giulia.giannini15@unibo.it', 'phone': '0039 051 4966959'}], 'overallOfficials': [{'name': 'Ilaria Cani', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Istituto delle Scienze Neurologiche di Bologna', 'class': 'OTHER'}, 'collaborators': [{'name': 'A.O.U. Città della Salute e della Scienza', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ilaria Cani', 'investigatorAffiliation': 'IRCCS Istituto delle Scienze Neurologiche di Bologna'}}}}