Status:
ACTIVE_NOT_RECRUITING
MST for Parkinson's Disease
Lead Sponsor:
University of British Columbia
Conditions:
Parkinson Disease
Depression
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This trial aims to test the feasibility of Magnetic Seizure Therapy (MST) for Depression in patients diagnosed with Parkinson's Disease.
Detailed Description
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 2...
Eligibility Criteria
Inclusion
- Are outpatient or inpatient persons capable of providing informed consent;
- ≥50 years old;
- Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria;
- Hoehn and Yahr stage between 1-4;
- MINI International Neuropsychiatric Interview diagnosis, Version 6 (MINI-6.0.) diagnosis of a current major depressive episode;
- IDS score of ≥22 (moderate/severe depression);
- Are on stable doses of psychotropic medication;
- Are considered to be appropriate to receive convulsive therapy as assessed by an attending psychiatrist and a consultant anaesthesiologist;
- 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;
- are able to adhere to the intervention schedule;
- meet the MST safety criteria;
Exclusion
- Current diagnosis of major neurocognitive disorder other than PD (eg. Multiple System Atrophy, Lewy Body Dementia) or dementia (Montreal Cognitive Assessment (MoCA) \<21)
- Current active psychosis;
- Have any of the cardiovascular risk factors listed on the Revised Cardiac Risk Index Score
- Unstable medical conditions that, in the opinion of the Principal Investigator, carries significant risk of exacerbation by either of the study interventions;
- Psychotropic medication initiation \<4 weeks prior to enrolment (two classes, antiparkinsonsian and antidepressant compounds);
- 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;
- 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;
- Are unable to communicate in English fluently enough to complete the neuropsychological tests;
- Have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).
- Have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04784494
Start Date
September 20 2021
End Date
February 1 2025
Last Update
December 20 2024
Active Locations (1)
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1
University of British Columbia
Vancouver, British Columbia, Canada, V6T2A1