Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784494
Status:
UNKNOWN
Last Update Posted:
2021-10-07
First Post:
2021-03-02
Brief Title:
MST for Parkinsons Disease
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Magnetic Seizure Therapy for Parkinsons Disease
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
RECRUITING
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 Parkinsons 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 Parkinsons disease and comorbid moderatesevere depression Research subjects will provide informed consent before enrollment and participation in any research proceduresThe study design follows international CONSORT guidelines for the reporting of results in feasibility trials
Treatment will be administered two days per week TuesdayThursday 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 Parkinsons disease
Hypothesis 1a Enrollment will be 70 of the planned target ie 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 TuesdayThursday 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 Parkinsons disease
Hypothesis 1a Enrollment will be 70 of the planned target ie 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:
None
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?:
None
Is an FDA AA801 Violation?:
None