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MST for Parkinson's Disease (MST-PD)

Primary Purpose

Parkinson Disease, Depression, Movement Disorders

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Magnetic Seizure Theapy (MagPro XP MST)

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Magnetic Seizure Therapy, MST, Convulsive Therapy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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).

Sites / Locations

University of British ColumbiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Magnetic Seizure Therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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

Enrollment will be ≥70% of the planned target.

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

Retention rate of randomized participants will be ≥70%

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%

Secondary Outcome Measures

Efficacy information to plan future definite trial

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. Inventory of Depressive Symptoms (IDS-30), Quick Inventory of Depressive Symptomatology (QIDS), and MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS).

Full Information

NCT ID

NCT04784494

First Posted

March 2, 2021

Last Updated

September 29, 2021

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT04784494

Brief Title

MST for Parkinson's Disease

Acronym

MST-PD

Official Title

Magnetic Seizure Therapy for Parkinson's Disease

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 20, 2021 (Actual)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease, Depression, Movement Disorders, Major Depressive Disorder

Keywords

Magnetic Seizure Therapy, MST, Convulsive Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Single-arm, open-label feasibility trial.

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Magnetic Seizure Therapy

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Magnetic Seizure Theapy (MagPro XP MST)

Other Intervention Name(s)

MagPro MST (Tonica Elektronik A/S, Denmark)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Enrollment will be ≥70% of the planned target.

Time Frame

18 months

Title

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

Description

Retention rate of randomized participants will be ≥70%

Time Frame

18 months

Title

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

Description

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

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Efficacy information to plan future definite trial

Description

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Michelle Avina, BSc

Phone

604-827-1361

michelle.avina@ubc.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fidel Vila-Rodriguez, MD, PhD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of British Columbia

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6T2A1

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michelle Avina, BSc

Phone

6048227308

michelle.avina@ubc.ca

First Name & Middle Initial & Last Name & Degree

Fidel Vila-Rodriguez, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

MST for Parkinson's Disease

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