TRPMS to Improve Mobility and Depression in Multiple Sclerosis

NYU Langone Health

Status: Withdrawn

Conditions: Multiple Sclerosis

Treatments: Device: TRPMS (Transcranial Rotating Permanent Magnet Stimulation); Other: Aerobic Exercise Program; Other: Computerized CT (Cognitive Training)

Study type: Interventional

Funder types: Other

Identifiers

NCT04578041

20-01101

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm 1: TRPMS + Aerobic Physical Activity Program

Experimental group

Treatment:

Device: TRPMS (Transcranial Rotating Permanent Magnet Stimulation)

Other: Aerobic Exercise Program

Arm 2: TRPMS + Adaptive Cognitive Training

Active Comparator group

Treatment:

Other: Computerized CT (Cognitive Training)

Device: TRPMS (Transcranial Rotating Permanent Magnet Stimulation)