Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT04784494
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-12-20
First Post:
2021-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MST for Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}], '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': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single-arm, open-label feasibility trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-18', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-02', 'lastUpdatePostDateStruct': {'date': '2024-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Feasibility of using MST to treat dPDT for depression in Parkinson's disease: recruitment", 'timeFrame': '18 months', 'description': 'Enrollment will be ≥70% of the planned target.'}, {'measure': "Feasibility of using MST to treat dPDT for depression in Parkinson's disease: retention", 'timeFrame': '18 months', 'description': 'Retention rate of randomized participants will be ≥70%'}, {'measure': "Feasibility of using MST to treat dPDT for depression in Parkinson's disease: side effects", 'timeFrame': '18 months', 'description': 'Drop out rates due to side effects will be ≤10%'}], 'secondaryOutcomes': [{'measure': 'Efficacy information to plan future definite trial', 'timeFrame': '18 months', 'description': "To obtain mean, SD, and 95% confidence intervals of potential outcome variables for the future RCT to estimate the sample size of the future RCT.\n\nInventory of Depressive Symptoms (IDS-30), Quick Inventory of Depressive Symptomatology (QIDS), and MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Magnetic Seizure Therapy', 'MST', 'Convulsive Therapy'], 'conditions': ['Parkinson Disease', 'Depression', 'Movement Disorders', 'Major Depressive Disorder']}, 'descriptionModule': {'briefSummary': "This trial aims to test the feasibility of Magnetic Seizure Therapy (MST) for Depression in patients diagnosed with Parkinson's Disease.", 'detailedDescription': "This is a phase II, single-arm open-label feasibility trial testing the feasibility of MST for dPD. The trial will occur over 18 months at one academic center in Canada (UBC). The enrollment goal is 20 patients with Parkinson's disease and comorbid moderate/severe depression. Research subjects will provide informed consent before enrollment and participation in any research procedures.The study design follows international CONSORT guidelines for the reporting of results in feasibility trials.\n\nTreatment will be administered two days per week (Tuesday/Thursday). This frequency has been chosen as research indicates that depression outcomes at the end of a course of ECT are similar between twice and thrice a week session, but twice a week sessions are associated with fewer cognitive side effects. Depression symptoms will be assessed with the Inventory for Depressive Symptoms. Response and remission will follow standard definition of decrease ≥50% (response) and IDS \\< 10 (remission). Patients will receive a maximum of 16 treatments. This maximum treatment number was chosen as the number of ECT treatments for an index course in depression is 12, but available data on MST indicates that MST may require more treatment sessions to achieve remission.\n\nAim 1. To evaluate the feasibility of using MST to treat dPD in preparation for a future definite superiority trial comparing active MST vs. sham MST for depression in Parkinson's disease.\n\nHypothesis 1a: Enrollment will be ≥70% of the planned target (i.e. 14 out of 20 participants).\n\nHypothesis 1b: Retention rate of randomized participants will be ≥70%.\n\nAim 2. To characterize the side effect profile of MST in dPD, with particular emphasis on cardiovascular and cognitive side effects.\n\nHypothesis 2a: Drop out rates due to side effects during treatment will be ≤10%\n\nAim 3: To obtain mean, SD, and 95% confidence intervals of potential outcome variables for the future RCT to estimate the sample size of the future RCT.\n\nAim 4: To explore the use of EEG as a biomarker of treatment response and correlate of response to MST"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Are outpatient or inpatient persons capable of providing informed consent;\n2. ≥50 years old;\n3. Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria;\n4. Hoehn and Yahr stage between 1-4;\n5. MINI International Neuropsychiatric Interview diagnosis, Version 6 (MINI-6.0.) diagnosis of a current major depressive episode;\n6. IDS score of ≥22 (moderate/severe depression);\n7. Are on stable doses of psychotropic medication;\n8. Are considered to be appropriate to receive convulsive therapy as assessed by an attending psychiatrist and a consultant anaesthesiologist;\n9. Patient may or may not be on antidepressant medication, but If on antidepressant medication, they should be agreeable to keep their current antidepressant treatment constant during the intervention;\n10. are able to adhere to the intervention schedule;\n11. meet the MST safety criteria;\n\nExclusion Criteria:\n\n1. Current diagnosis of major neurocognitive disorder other than PD (eg. Multiple System Atrophy, Lewy Body Dementia) or dementia (Montreal Cognitive Assessment (MoCA) \\<21)\n2. Current active psychosis;\n3. Have any of the cardiovascular risk factors listed on the Revised Cardiac Risk Index Score\n4. Unstable medical conditions that, in the opinion of the Principal Investigator, carries significant risk of exacerbation by either of the study interventions;\n5. Psychotropic medication initiation \\<4 weeks prior to enrolment (two classes, antiparkinsonsian and antidepressant compounds);\n6. Have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed;\n7. Require a benzodiazepine dose \\> 2mg/day of lorazepam or equivalent dose or are on any anticonvulsant due to the potential of these medications to limit the efficacy of MST;\n8. Are unable to communicate in English fluently enough to complete the neuropsychological tests;\n9. Have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).\n10. Have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests)."}, 'identificationModule': {'nctId': 'NCT04784494', 'acronym': 'MST-PD', 'briefTitle': "MST for Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': "Magnetic Seizure Therapy for Parkinson's Disease", 'orgStudyIdInfo': {'id': 'H19-01049'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnetic Seizure Therapy', 'description': 'MST treatments will be administered using the MagPro XP MST with Cool TwinCoil.', 'interventionNames': ['Device: Magnetic Seizure Theapy (MagPro XP MST)']}], 'interventions': [{'name': 'Magnetic Seizure Theapy (MagPro XP MST)', 'type': 'DEVICE', 'otherNames': ['MagPro MST (Tonica Elektronik A/S, Denmark)'], 'description': 'MST treatment will be administered over the frontal/vertex cortex using 100 Hz stimulation using the MagPro XP MST with Cool TwinCoil. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).\n\nMST treatments will be administered twice a week, for up to 16 treatments. This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes.', 'armGroupLabels': ['Magnetic Seizure Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6T2A1', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Fidel Vila-Rodriguez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Fidel Vila-Rodriguez', 'investigatorAffiliation': 'University of British Columbia'}}}}