MST for Parkinson's Disease

NCT04784494 | Active Not Recruiting

• 1 other identifier: H19-01049
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Parkinson Disease; Depression; Movement Disorders; Major Depressive Disorder

Keywords

Magnetic Seizure Therapy; MST; Convulsive Therapy

Outcome Measures

Primary Outcomes (3)

• Feasibility of using MST to treat dPDT for depression in Parkinson's disease: recruitment

  Enrollment will be ≥70% of the planned target.

  18 months

• Feasibility of using MST to treat dPDT for depression in Parkinson's disease: retention

  Retention rate of randomized participants will be ≥70%

  18 months

• Feasibility of using MST to treat dPDT for depression in Parkinson's disease: side effects

  Drop out rates due to side effects will be ≤10%

  18 months

Secondary Outcomes (1)

• Efficacy information to plan future definite trial

  18 months

Study Arms (1)

Magnetic Seizure Therapy

EXPERIMENTAL

MST treatments will be administered using the MagPro XP MST with Cool TwinCoil.

Device: Magnetic Seizure Theapy (MagPro XP MST)

Interventions

Magnetic Seizure Theapy (MagPro XP MST) DEVICE

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.

Also known as: MagPro MST (Tonica Elektronik A/S, Denmark)

Magnetic Seizure Therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T2A1, Canada

Location

MeSH Terms

Conditions

Parkinson Disease; Depression; Movement Disorders; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Fidel Vila-Rodriguez, MD, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Single-arm, open-label feasibility trial.

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: September 20, 2021
• Primary Completion: July 1, 2024
• Study Completion: February 1, 2025
• Last Updated: December 20, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)