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:
University of British Columbia
Organization:
Study Overview
Official Title:
Magnetic Seizure Therapy for Parkinson's Disease
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MST-PD
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 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.
Treatment 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.
Aim 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.
Hypothesis 1a: Enrollment will be ≥70% of the planned target (i.e. 14 out of 20 participants).
Hypothesis 1b: Retention rate of randomized participants will be ≥70%.
Aim 2. To characterize the side effect profile of MST in dPD, with particular emphasis on cardiovascular and cognitive side effects.
Hypothesis 2a: Drop out rates due to side effects during treatment will be ≤10%
Aim 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.
Aim 4: To explore the use of EEG as a biomarker of treatment response and correlate of response to MST
Treatment 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.
Aim 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.
Hypothesis 1a: Enrollment will be ≥70% of the planned target (i.e. 14 out of 20 participants).
Hypothesis 1b: Retention rate of randomized participants will be ≥70%.
Aim 2. To characterize the side effect profile of MST in dPD, with particular emphasis on cardiovascular and cognitive side effects.
Hypothesis 2a: Drop out rates due to side effects during treatment will be ≤10%
Aim 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.
Aim 4: To explore the use of EEG as a biomarker of treatment response and correlate of response to MST
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: