TRPMS to Improve Mobility and Depression in Multiple Sclerosis
NCT ID: NCT04578041
Last Updated: 2023-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-01-01
2023-03-05
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1: TRPMS + Aerobic Physical Activity Program
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
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.
Arm 2: TRPMS + Adaptive Cognitive Training
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
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.
Interventions
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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
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.
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.
Eligibility Criteria
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Inclusion 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
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)
18 Years
70 Years
ALL
No
Sponsors
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NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Leigh Charvet, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Other Identifiers
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20-01101
Identifier Type: -
Identifier Source: org_study_id