Transcranial Magnetic Stimulation for Depression in Multiple Sclerosis

AL
Overseen ByAnna L Bourgeois, MSc.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: University of Calgary
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a non-invasive treatment called repetitive transcranial magnetic stimulation (rTMS) can improve depression and fatigue in people with multiple sclerosis (MS). rTMS uses magnetic pulses to stimulate specific brain areas to relieve symptoms that haven't responded well to other treatments. It targets individuals with relapsing-remitting or primary-progressive MS who experience moderate to severe depression and significant fatigue. Participants will undergo daily brain stimulation sessions for five days and will be monitored for changes in mood and energy levels. The study aims to determine if rTMS is a safe and effective option for MS-related depression and fatigue. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, it requires that your immunotherapy be stable for at least 3 months and other medications for at least 4 weeks before joining the study.

What prior data suggests that this technique is safe for treating depression in individuals with multiple sclerosis?

Studies have shown that repetitive transcranial magnetic stimulation (rTMS) is generally a safe treatment for major depressive disorder (MDD). Research indicates that adults usually tolerate rTMS well, with most experiencing only mild side effects, such as headaches or slight discomfort at the treatment site. These side effects typically resolve quickly after the session.

rTMS is a non-invasive treatment, meaning it doesn't involve surgery or entering the body. It uses magnetic pulses to stimulate specific parts of the brain. Health Canada has approved rTMS as a first-choice treatment for MDD, indicating it has passed safety tests for this condition.

Although rTMS is approved for treating depression, it hasn't been widely tested in people with multiple sclerosis (MS). This clinical trial aims to explore its safety in people with MS. As an early-phase trial, the main focus is on safety and how well participants tolerate the treatment. Researchers are still collecting data to confirm its safety for MS patients.12345

Why do researchers think this study treatment might be promising?

Repetitive Transcranial Magnetic Stimulation (rTMS) is unique because it directly targets the brain's left dorsolateral prefrontal cortex, a region associated with mood regulation. Unlike standard treatments for depression in multiple sclerosis, which often involve medications like antidepressants, rTMS uses magnetic fields to stimulate nerve cells non-invasively. This method offers a novel mechanism of action that could potentially show rapid improvements in mood without the systemic side effects commonly seen with pharmaceuticals. Researchers are excited about rTMS because it provides a targeted, personalized approach, as the treatment is tailored using MRI and electric field modeling to avoid areas with demyelinating lesions, ensuring safety and effectiveness.

What evidence suggests that rTMS might be an effective treatment for depression in MS?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) can effectively treat major depressive disorder (MDD). Studies also suggest that rTMS might help reduce depression and fatigue in people with multiple sclerosis (MS). For example, one study found that rTMS often benefited MS patients with these symptoms. Another study showed that up to 74% of patients responded positively to rTMS, leading to significant mood improvements. The chances of achieving remission with rTMS were more than four times higher compared to a placebo, highlighting its potential effectiveness for depression. In this trial, participants will receive stimulation targeting the left dorsolateral prefrontal cortex to evaluate its safety, feasibility, and preliminary clinical effects.23467

Who Is on the Research Team?

AG

Adrianna Giuffre, PhD.

Principal Investigator

Cumming School of Medicine, University of Calgary

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with multiple sclerosis (MS) who have moderate to severe depression and significant fatigue, haven't responded well to at least one antidepressant or therapy, are on stable medications, and can safely undergo MRI and TMS procedures.

Inclusion Criteria

I have been on the same immunotherapy for at least 3 months and other meds for 4 weeks.
9. Have no contraindications to TMS or magnetic resonance imaging.
My disability score is less than 7 on the EDSS scale.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants receive daily TMS sessions for 5 consecutive days, including pre-TMS brain mapping and five rTMS treatments per day

1 week
5 visits (in-person)

Post-treatment Assessment

Participants complete post-treatment assessments including questionnaires, cognitive tests, and psychiatric evaluation

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a 4-week follow-up visit

4 weeks
1 visit (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Repetitive Transcranial Magnetic Stimulation (rTMS)

Trial Overview

The study tests if repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain treatment using magnetic pulses, can safely improve depression and fatigue in people with MS. Participants receive daily rTMS sessions over five days along with assessments before, after, and at follow-up.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Stimulation to the Left Dorsolateral Prefrontal Cortex (DLPFC)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Calgary

Lead Sponsor

Trials
827
Recruited
902,000+

Hotchkiss Brain Institute, University of Calgary

Collaborator

Trials
12
Recruited
2,400+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37048608/

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