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TRPMS to Improve Mobility and Depression in Multiple Sclerosis

NCT04578041 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-12-28

No results posted yet for this study

Summary

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).

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Leigh Charvet, PhD · NYU Langone Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-03-05
Completion
2023-03-05
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04578041 on ClinicalTrials.gov