TRPMS to Improve Mobility and Depression in Multiple Sclerosis
An Open Label Pilot Study to Investigate the Effect of Transcranial Rotating Permanent Magnetic Stimulation (TRPMS) on Gait, Balance and Depression in People With Multiple Sclerosis (MS)
What it found
The trial ended early for another reason (see below).
Reason given: Lack of funding
What was tested
Treatment tested
- Aerobic Exercise Program
Compared with
- Computerized CT (Cognitive Training)
Given to everyone in the trial
- TRPMS (Transcranial Rotating Permanent Magnet Stimulation)
What it measured
Main measures
Percent of Sessions Completed
Day 10
FeasibilityChange in Gait Velocity
Baseline (Day 0), Day 10
Walking and mobilityPhysical functionChange in PROMIS Depression Score
Baseline (Day 0), Day 10
Mood and sleep
Other measures (9)
Change in Gait Velocity
Baseline (Day 0), Week 4
Walking and mobilityChange in Distance Traveled During 2-Minute Walking Test
Baseline (Day 0), Day 10
Walking and mobilityChange in the Total Time for Completing the Timed Up and Go (TUG) test
Baseline (Day 0), Day 10
Walking and mobilityChange in Modified Fatigue Impact Scale (MFIS) Score
Baseline (Day 0), Day 10
FatigueChange in Short Form (SF)-36 Score
Baseline (Day 0), Day 10
Quality of life (reported by participants)Change in PROMIS Depression Score
Baseline (Day 0), Week 4
Mood and sleepChange in Center for Epidemiological Studies-Depression short form (CESD-10) Score
Baseline (Day 0), Day 10
Mood and sleepChange in Patient Health Questionnaire 9 (PHQ-9) Score
Baseline (Day 0), Day 10
Mood and sleepChange in Inventory of Depressive Symptomatology Self-Report (IDS-SR) Score
Baseline (Day 0), Day 10
Mood and sleep
Who could take part
Relapsing and progressive · 18 to 70
Show the full criteria
Inclusion criteria
In order to be eligible to participate in Arm 1 of this study, an individual must meet all of the following criteria: 1. Between ages 18 - 70 2. SDMT z-score ≥ -3.0 3. Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition scaled score ≥ 85 4. Definite MS diagnosis as assessed by a licensed physician (all subtypes - RRMS, PPMS, SPMS) 5. Expanded Disability Status Scale (EDSS) ≤ 6.5 6. Clinically stable disease course with absence of relapse within the past 30 days 7. Able to understand the informed consent process and provide consent to participate in the study 8. Complete the TMS screening questionnaire 9. Able to commit to study timeframe 10. Clinically significant gate deviations (T25-FW > 5.0 seconds) 11. Able to walk independently with or without assistive device (i.e. cane, crutches, or walking frames) for medium distance 12. Able to exercise with seated elliptical machine In order to be eligible to participate in Arm 2 of this study, an individual must meet all of the following criteria: 1. Between ages 18 - 70 2. SDMT z-score ≥ -3.0 3. Wide Range Achievement Test-4th Edition (WRAT-4) Reading Recognition scaled score ≥ 85 4. Definite MS diagnosis as assessed by a licensed physician (all subtypes - RRMS, PPMS, SPMS) 5. Expanded Disability Status Scale (EDSS) ≤ 6.5 6. Clinically stable disease course with absence of relapse within the past 30 days 7. Able to understand the informed consent process and provide consent to participate in the study 8. Complete the TMS screening questionnaire 9. Able to commit to study timeframe 10. Elevated symptoms of depression as determined by BDI of ≥ 4
Exclusion criteria
1. Visual, auditory or motor deficits that would influence participant safety as assessed by a licensed physician 2. History of seizure or epileptic history as assessed by licensed physician 3. Medication which significantly lower the seizure threshold as assessed by licensed physician 4. Primary psychiatric disorder that would influence ability to participate 5. Uncontrolled headaches and migraine or recent changes in the rate or severity of head pressure, headache, or migraine in the past two weeks 6. History of stroke or head trauma (e.g., head injury, brain surgery) or medical device implanted in the head (e.g. Deep Brain Stimulator) or in the neck (e.g. Vagus Nerve Stimulator) 7. History of uncontrolled or labile hypertension 8. Other serious uncontrolled medical condition or recent medical traumas 9. Presence of metal or electronic implants in the body contraindicated for TMS 10. Alcohol or other substance use disorder 11. Pregnant or breastfeeding 12. History of clinically significant abnormalities on electrocardiogram (EKG) (Arm 1 only) 13. Presence of chronic medical illness and/or severe ataxia (Arm 1 only) 14. Functional surgery for lower limb in the past 6 months (e.g. hip or knee replacement) (Arm 1 only) 15. Lower limb Botulinum toxin injection within the past 2 months (Arm 1 only)
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study is aimed to test the efficacy of 10 sessions of Transcranial Rotating Permanent Magnetic Stimulation (TRPMS) paired with aerobic exercise or computerized cognitive training (CT) on mobility and depression symptoms in 40 individuals affected by multiple sclerosis (MS). Participants in Arm 1 will complete 10x40 minutes daily sessions of TRPMS+aerobic exercise. Participants in Arm 2 will complete TRPMS+computerized CT. Primary outcomes for both arms will be assessed at baseline, at treatment end and after 4-week from the treatment end (follow-up).
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History
Started
Jan 2023
Main results due
Mar 2023
Finished
Mar 2023