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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Repetitive Transcranial Magnetic Stimulation (rTMS)
DeviceTreatment 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).
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Stimulation to the Left Dorsolateral Prefrontal Cortex (DLPFC)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Presence of demyelinating lesions within the TMS-induced electric field and downstream projections (Safety)
Overlap between individualized TMS electric field modeling and demyelinating lesions identified on MRI, including cortical target and tractography-defined downstream pathways.
Time frame
Baseline (prior to intervention)2
Clinical Global Impression-Severity and -Improvement scales (CGI-S, CGI-I)
The CGI provides an overall clinician-determined summary measure that takes into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.
Time frame
Baseline, Day 5 (post-treatment), and 4-week follow-up3
Montgomery-Åsberg Depression Rating Scale (MADRS)
The Montgomery-Asberg Rating Scale (MADRS) is a 10-item clinician-rated assessment for depression in adults (18+). The MADRS focusses more upon functional impairment and somatic symptoms than other assessments which might focus more upon depressive cognitive attitudes (Montgomery and Asberg, 1979).
Time frame
Baseline, Day 5 (post-treatment), and 4-week follow-up4
17-item Hamilton Rating Scale for Depression (HAM-D-17)
The 17-item Hamilton Rating Scale for Depression (HAM-D-17) is a widely used clinician-rated tool to assess the severity of depressive symptoms, focusing on mood, guilt, suicide, insomnia, work/activity, retardation, agitation, anxiety, somatic symptoms, and weight loss.
Time frame
Baseline, Day 5 (post-treatment), and 4-week follow-upSecondary outcomes
1
TMS Safety and Tolerability
Tolerability of intermittent theta burst stimulation (iTBS) will be assessed using a standardized TMS Safety and Tolerability Questionnaire administered before and after each treatment day. Measures will include participant-reported discomfort, pain, headache, scalp irritation, and other stimulation-related side effects, as well as the need for stimulation intensity adjustments or treatment discontinuation due to intolerance.
Time frame
Daily during the 5-day treatment period and at post-treatment assessment (Day 5)2
Fitness watch data
Participants will be provided with a fitness watch that will synch with a research app to collect sleep, actigraphy, and heart rate variability data. Continuous data transfer from the fitness watch will occur over the course of the treatment and follow-up periods for sleep and heart rate. Participants will aim to wear watches all the time and record when they take them off.
Time frame
Watches will be given at the baseline session and be worn until the last follow-up session. (4 weeks after the intervention).3
The Quick Inventory of Depressive Symptomatology - Self-Report (QIDS-SR)
A brief, 16-item self-assessment tool used to measure the severity of depressive symptoms over the past week, covering key areas like sleep, mood, appetite, energy, and concentration.
Time frame
Time Frame: Baseline, Day 5 (post-treatment), 4-week follow-up4
Generalized Anxiety Disorder 7-item scale (GAD-7)
A screening tool for generalized anxiety.
Time frame
Time Frame: Baseline, Day 5 (post-treatment), 4-week follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Calgary
Lead sponsor
Hotchkiss Brain Institute, University of Calgary
Collaborator
Source ClinicalTrials.gov
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