Wearable focal vibration to improve arm and hand function in relapsing-remitting MS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This mixed-methods pilot will enroll 15 adults with relapsing-remitting MS and self-reported upper extremity impairments to test a 4-week home-based program using Myovolt wearable focal vibration devices applied to arm muscles. Participants will be trained on device use, complete home therapy sessions, and attend laboratory visits at the University of Florida for baseline and follow-up assessments. Outcomes include feasibility metrics, preliminary measures of upper extremity motor function, and qualitative interviews about user experience. The protocol excludes recent relapses and significant cognitive or other neurological comorbidities to maintain symptom stability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged over 18 years
* Confirmed diagnosis of RRMS according to the McDonald criteria (33)
* No MS relapse or exacerbation within the past 6 months (ensuring stability of symptoms)
* Self-report on clinical evidence of UEx impairment (including reduced arm/hand function, muscle weakness, spasticity, or pain).
* Stable on MS treatment for at least four weeks before recruitment, with no plans to initiate new treatments (participants may continue current treatments during the study)
* Agree and are able to use the FVT device after training.
* Sufficient proficiency in English to participate in interviews and follow instructions
* Able to visit the laboratory for assessments
* Able to provide written informed consent

Exclusion Criteria:

* Evidence of cognitive impairment that could interfere with following instructions (Mini-Montreal Cognitive Assessment score (Mini-MoCA) \< 12)
* Comorbid neurological or psychiatric conditions affecting the UEx (including stroke and severe carpal tunnel syndrome) that would confound results or make FVT unsafe
* Unstable cardiac disease or any major medical illness that would preclude participation
* Any known contraindications to vibration therapy (pregnancy, acute deep vein thrombosis, severe osteoporosis, chronic migraines, epilepsy, active malignancy in the target area, unstable cardiac disease, or an implanted pacemaker without clearance)

Where it's running

• Norman Fixel Institute for Neurological Diseases
  Gainesville, Florida, United States Recruiting
• University of Florida
  Gainesville, Florida, United States Recruiting

Study contacts

• Principal investigator: Hongwu Wang — University of Florida
• Study coordinator: Hongwu Wang, PhD
• Email: hongwu.wang@ufl.edu
• Phone: 352-273-9934

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.