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ACTIVE NOT RECRUITING

NCT04784494

MST for Parkinson's Disease

Sponsor: University of British Columbia

View on ClinicalTrials.gov

Summary

This trial aims to test the feasibility of Magnetic Seizure Therapy (MST) for Depression in patients diagnosed with Parkinson's Disease.

Official title: Magnetic Seizure Therapy for Parkinson's Disease

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2021-09-20

Completion Date

2025-02

Last Updated

2024-12-20

Healthy Volunteers

Conditions

Parkinson Disease Depression Movement Disorders Major Depressive Disorder

Interventions

DEVICE

Magnetic Seizure Theapy (MagPro XP MST)

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). MST 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.

Inclusion Criteria: 1. Are outpatient or inpatient persons capable of providing informed consent; 2. ≥50 years old; 3. Confirmed diagnosis of Parkinson's disease based on UK Brain Bank criteria; 4. Hoehn and Yahr stage between 1-4; 5. MINI International Neuropsychiatric Interview diagnosis, Version 6 (MINI-6.0.) diagnosis of a current major depressive episode; 6. IDS score of ≥22 (moderate/severe depression); 7. Are on stable doses of psychotropic medication; 8. Are considered to be appropriate to receive convulsive therapy as assessed by an attending psychiatrist and a consultant anaesthesiologist; 9. 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; 10. are able to adhere to the intervention schedule; 11. meet the MST safety criteria; Exclusion Criteria: 1. Current diagnosis of major neurocognitive disorder other than PD (eg. Multiple System Atrophy, Lewy Body Dementia) or dementia (Montreal Cognitive Assessment (MoCA) \<21) 2. Current active psychosis; 3. Have any of the cardiovascular risk factors listed on the Revised Cardiac Risk Index Score 4. Unstable medical conditions that, in the opinion of the Principal Investigator, carries significant risk of exacerbation by either of the study interventions; 5. Psychotropic medication initiation \<4 weeks prior to enrolment (two classes, antiparkinsonsian and antidepressant compounds); 6. 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; 7. 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; 8. Are unable to communicate in English fluently enough to complete the neuropsychological tests; 9. Have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests). 10. Have a non-correctable clinically significant sensory impairment (i.e., cannot hear or see well enough to complete the neuropsychological tests).

Locations (1)

University of British Columbia

Vancouver, British Columbia, Canada