Transcranial Magnetic Stimulation for Depression in Multiple Sclerosis

Sponsor
University of Calgary
Study ID
NCT07562074
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS) — DEVICE
    Treatment of iTBS for 5 consecutive days. iTBS will involve 600 pulses per session delivered as triplets of 50Hz repeated at 5Hz at 80% resting motor threshold (rMT).

Study Details

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.

Key Dates

First listed
May 1, 2026
Start date
Jun 15, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Stimulation to the Left Dorsolateral Prefrontal Cortex (DLPFC)
    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.

Primary Outcome Measure

Presence of demyelinating lesions within the TMS-induced electric field and downstream projections (Safety) [ Time Frame: Baseline (prior to intervention) ]

Central Contacts

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