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Procedure
Transcranial Magnetic Stimulation for Depression (ReDeeMD Trial)
N/A
Recruiting
Led By Jean-Philippe Miron, MD PhD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
ReDeeMD Trial Summary
This trial will compare two TMS techniques in people with Major Depressive Disorder to see which works better. It will also evaluate biomarkers to predict response.
Who is the study for?
This trial is for adults with Major Depressive Disorder who haven't improved after two different antidepressants, are on a stable medication regimen, and have a moderate to severe depression score. It's not for those who've had TMS before, have bipolar/psychosis or primary anxiety disorders, unstable medical conditions, recent substance abuse, certain implants, significant lab abnormalities or are pregnant.Check my eligibility
What is being tested?
The study compares repetitive TMS (rTMS) and deep TMS (dTMS) in treating treatment-resistant depression. Participants will be randomly assigned to one of these two techniques to see if dTMS is more effective than rTMS and to test the use of biomarkers in predicting outcomes.See study design
What are the potential side effects?
Common side effects of both rTMS and dTMS can include discomfort at the stimulation site during treatment sessions, headache following treatment, lightheadedness or tingling sensations. Rarely seizures may occur.
ReDeeMD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 6, week 7, week 10, week 18
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 6, week 7, week 10, week 18
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hamilton Rating Scale for Depression-17 (HRSD-17)
Secondary outcome measures
Adult AHDH Self-Report Scale
Cognitive Difficulties Scale (MacNair-R)
Columbia-Suicide Severity Rating Scale (C-SSRS)
+14 moreOther outcome measures
Electrocardiogram
Electroencephalogram event-related potentials
Electroencephalogram to predict treatment response
+1 moreReDeeMD Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: deep Transcranial Magnetic StimulationExperimental Treatment1 Intervention
dTMS on a research Brainsway system equipped with an H7-Coil. Participants will receive the MDD FDA-cleared 18 Hz stimulation protocol (2 sec ON, 20 sec OFF, 55 trains; 1980 pulses per session; 20 min 10 s duration; 120% hand motor threshold)
Group II: repetitive Transcranial Magnetic StimulationActive Control1 Intervention
rTMS on a MagPro X100 research grade stimulator (MagVenture) equipped with a B70 fluid-cooled coil. Participant will receive the MDD FDA-approved iTBS protocol (triplet 50 Hz bursts repeated at 5 Hz, 2 s ON and 8 s OFF; 600 pulses per session; total duration of 3 min 9 s, 120% hand motor threshold)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
transcranial magnetic stimulation
2013
Completed Phase 2
~710
Find a Location
Who is running the clinical trial?
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
366 Previous Clinical Trials
129,587 Total Patients Enrolled
1 Trials studying Depression
18 Patients Enrolled for Depression
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,464 Total Patients Enrolled
45 Trials studying Depression
3,273,323 Patients Enrolled for Depression
Jean-Philippe Miron, MD PhDPrincipal InvestigatorCentre de Recherche du Centre Hospitalier de l'Université de Montréal
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does my profile meet the prerequisites to be part of this trial?
"To be eligible to participate in this trial, individuals must have been diagnosed with depression and fall within the age range of 21-70. The team is hoping to enrol a total of 220 people."
Answered by AI
Does the trial have an age restriction, and if so, what is it?
"The delimitation parameters of this study necessitate that applicants are between 21 and 70 years old. For those younger than 18, there are 121 other studies which may be suitable; for seniors over 65, 641 clinical trials exist."
Answered by AI
Is this investigation currently actively enrolling participants?
"According to the records on clinicaltrials.gov, this medical research project is currently not recruiting patients. Initially posted in November 1st 2023 and last updated October 26th 2023, recruitment has been paused for now; yet there are 887 other active studies that may be of interest."
Answered by AI
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