NCT04578041

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)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

• Multiple Sclerosis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-03-05
• Completion: 2023-03-05
• First posted: 2020-10-08
• Last updated: 2023-12-28

Regulatory

• FDA-regulated device study