Transcranial Magnetic Stimulation for Depression in Multiple Sclerosis
What You Need to Know Before You Apply
What is the purpose of this trial?
Canada has one of the highest rates of multiple sclerosis (MS). MS patients experience disabling motor, visual, and sensory symptoms, and a high risk of comorbid major depressive disorder (MDD) and severe fatigue. The lifetime prevalence of MDD in MS patients is about 50%, and nearly 90% experience severe fatigue, both of which are not responsive to typical treatments. Repetitive transcranial magnetic stimulation (rTMS) is a first line, Health Canada approved non-invasive neurostimulation treatment for MDD. rTMS induces electrical activity in the cortex using magnetic fields generated outside of the head to drive neuronal firing in the target site. However, MS is typically an exclusion criterion due to safety concerns.
The goal of this clinical trial is to learn if repeated transcranial magnetic stimulation (rTMS) can be used to treat depression symptoms in adults with multiple sclerosis (MS). rTMS is a non-invasive form of brain stimulation that uses magnetic pulses to stimulate specific parts of the brain.
The main questions it aims to answer are:
Is rTMS safe, tolerable, and feasible to deliver as a treatment for depression and fatigue symptoms in individuals with MS? Does rTMS show preliminary effectiveness in improving depression and fatigue symptoms in this population?
Researchers will determine whether rTMS treatment improves mood, fatigue, and cognition across time points (baseline, after treatment, and 4-week follow-up).
Participants will: Complete screening, questionnaires, clinical assessments, cognitive tests, a brain MRI to help tailor the TMS treatment, and receive daily TMS sessions for 5 consecutive days, including: Pre-TMS brain mapping, five rTMS treatments (3 minutes) per day, separated by one hour. A safety and tolerability questionnaire will be administered daily. Complete post-treatment assessments (questionnaires, cognitive tests, psychiatric evaluation). Complete a 4-week follow-up visit, in person or virtually. Wear a fitness tracking watch during the study so researchers can collect activity data remotely.
About 20 people will take part in this study through the University of Calgary.
Who Is on the Research Team?
Adrianna Giuffre, PhD.
Principal Investigator
Cumming School of Medicine, University of Calgary
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive daily TMS sessions for 5 consecutive days, including pre-TMS brain mapping and five rTMS treatments per day
Post-treatment Assessment
Participants complete post-treatment assessments including questionnaires, cognitive tests, and psychiatric evaluation
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a 4-week follow-up visit
What Are the Treatments Tested in This Trial?
Interventions
- Repetitive Transcranial Magnetic Stimulation (rTMS)
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive intermittent theta burst stimulation (iTBS) targeting the left dorsolateral prefrontal cortex (Magstim D70 AFC Air Film coil). Prior to treatment, participants will undergo magnetic resonance imaging and individualized electric field modeling to ensure that the stimulation target and its downstream projections do not overlap with demyelinating lesions. iTBS will be delivered at 80% of resting motor threshold, consisting of 600 pulses per session administered as triplets at 50 Hz repeated at 5 Hz. Treatments will be delivered five times per day, with a one-hour inter-session interval, over five consecutive weekdays. Clinical, cognitive, and neurophysiological outcome measures will be assessed at baseline, post-treatment, and at -week follow-up to evaluate safety, feasibility, and preliminary clinical effects.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Hotchkiss Brain Institute, University of Calgary
Collaborator
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