Not Yet RecruitingPhase 1

Transcranial Magnetic Stimulation for Depression in Multiple Sclerosis

Canada20 participantsStarted 2026-06-15

Plain-language summary

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 can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18-65 years of age, inclusive.
✓. Males, females, and non-binary.
✓. Clinical diagnosis of relapsing-remitting or primary-progressive multiple sclerosis according to the revised McDonald criteria and as determined by the study neurologist and medical records.
✓. Expanded Disability Status Scale score \<7.
✓. Fatigue Severity Scale ≥ 4.
✓. Moderate to severe major depressive disorder as defined by a Hamilton Depression Rating Scale-17 item score ≥18.
✓. Did not benefit adequately from ≥ 1 antidepressant or course of psychotherapy.
✓. Stable immunotherapy for at least 3 months and medications for at least 4 weeks.

Exclusion criteria

✕. Presence of any disease, medical condition, or physical condition that, in the opinion of the study investigator, study psychiatrist, or study neurologist, may compromise interfere, limit, affect, or reduce the study subject's ability to complete the study.

What they're measuring

Presence of demyelinating lesions within the TMS-induced electric field and downstream projections (Safety)

Timeframe: Baseline (prior to intervention)

Clinical Global Impression-Severity and -Improvement scales (CGI-S, CGI-I)

Timeframe: Baseline, Day 5 (post-treatment), and 4-week follow-up

Montgomery-Åsberg Depression Rating Scale (MADRS)

Timeframe: Baseline, Day 5 (post-treatment), and 4-week follow-up

17-item Hamilton Rating Scale for Depression (HAM-D-17)

Timeframe: Baseline, Day 5 (post-treatment), and 4-week follow-up

Columbia-Suicide Severity Rating Scale (C-SSRS).

Timeframe: Baseline, Day 5 (post-treatment), and 4-week follow-up

Trial details

NCT IDNCT07562074

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Anna L Bourgeois, MSc.

4039887901 anna.bourgeois@ucalgary.ca

View on ClinicalTrials.gov More Multiple Sclerosis trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 18-65 years of age, inclusive.
✓. Males, females, and non-binary.
✓. Clinical diagnosis of relapsing-remitting or primary-progressive multiple sclerosis according to the revised McDonald criteria and as determined by the study neurologist and medical records.
✓. Expanded Disability Status Scale score \<7.
✓. Fatigue Severity Scale ≥ 4.
✓. Moderate to severe major depressive disorder as defined by a Hamilton Depression Rating Scale-17 item score ≥18.
✓. Did not benefit adequately from ≥ 1 antidepressant or course of psychotherapy.
✓. Stable immunotherapy for at least 3 months and medications for at least 4 weeks.

Exclusion criteria

✕. Presence of any disease, medical condition, or physical condition that, in the opinion of the study investigator, study psychiatrist, or study neurologist, may compromise interfere, limit, affect, or reduce the study subject's ability to complete the study.

What they're measuring

Presence of demyelinating lesions within the TMS-induced electric field and downstream projections (Safety)