Transcranial Magnetic Stimulation for Depression in Multiple Sclerosis
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of Calgary
About 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Presence of any disease, medical condition, or physical condition that, in the opinion of the study investigator, study psychiatrist, or study neurologist, may adversely impact the safety of the study subject or the integrity of the data.
History of seizures.
Any cranial metal implants (excluding ≤ 1mm thick epicranial titanium skull plates and dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant).
Trial design
Treatments tested in this trial
- Repetitive Transcranial Magnetic Stimulation (rTMS)
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Calgary
Lead sponsor
Hotchkiss Brain Institute, University of Calgary
Collaborator
Source ClinicalTrials.gov