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TRPMS to Improve Mobility and Depression in Multiple Sclerosis

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion 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.

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04578041
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	NYU Langone Health
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Leigh Charvet, PhD
Principal Investigator Affiliation	NYU Langone Health
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis

Arms & Interventions

Arms

Experimental: Arm 1: TRPMS + Aerobic Physical Activity Program

Active Comparator: Arm 2: TRPMS + Adaptive Cognitive Training

Interventions

Device: - TRPMS (Transcranial Rotating Permanent Magnet Stimulation)

TRPMS ( is administered through a head cap worn by the participant and controlled by QHTimeStimulate application via computer tablet. Modality: Excitatory stimulation Frequency: 5 Hz Interval between stimulus: 100 ms Duration of each stimulus: 25 ms Duration of stimulation: 40 minutes Position of microstimulators: over primary motor cortex and supplementary motor area for Arm 1; over left and right dorsolateral prefrontal cortex for Arm 2

Other: - Aerobic Exercise Program

Aerobic exercise consisting of 40 minutes of cycling training with a seated elliptical machine. The daily physical activity program will consist of three 10-minute bouts of aerobic exercise interspersed with two 5-minute bouts of rest. The participants will exercise maintaining their Heart Rate (HR) at least between 60-80% of the maximum age-related HR.

Other: - Computerized CT (Cognitive Training)

Computerized cognitive training (CT) consisting of 40 minutes Brain-HQ training. The adaptive cognitive training games also serve to engage them during the stimulation session, and to keep them seated at the computer for the entire duration of the session.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Leigh Charvet, PhD

[email protected]

929-455-5141

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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