Wearable Focal Vibration Therapy for Multiple Sclerosis

HW
Overseen ByHongwu Wang, PhD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new home-based therapy called Wearable Focal Vibration Therapy to help people with multiple sclerosis (MS) improve arm function. The therapy uses a wearable device that sends gentle vibrations to arm muscles. The goal is to determine if this treatment can make arm movements easier and less painful. People with relapsing-remitting MS who have trouble using their arms or hands and haven't experienced an MS flare-up in the last six months are suitable candidates for this study. Participants will try the therapy for four weeks and share their experiences. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to experience this innovative therapy.

Will I have to stop taking my current medications?

No, you can continue taking your current medications during the study as long as your treatment has been stable for at least four weeks before joining the trial.

What prior data suggests that this wearable Focal Vibration Therapy is safe for people with multiple sclerosis?

Earlier studies have found wearable Focal Vibration Therapy (FVT) to be safe and easy to tolerate. Research shows that similar vibration therapies are simple to use and have few side effects. For instance, one study demonstrated that wearable FVT improved mobility in people with multiple sclerosis without causing serious problems. Participants in these studies reported the therapy as comfortable and easy to use.

As this trial begins, it primarily focuses on testing the treatment's safety and tolerability. Ensuring participant safety is a top priority. Prospective participants should know that past research supports the safety of this type of therapy.12345

Why do researchers think this study treatment might be promising?

Wearable Focal Vibration Therapy is unique because it offers a non-invasive approach to managing symptoms of Multiple Sclerosis (MS). Unlike traditional treatments, which often include medications like interferons or oral drugs that modulate the immune system, this therapy uses targeted vibrations to potentially improve muscle function and reduce spasticity. Researchers are excited about this therapy because it represents a new delivery method that could complement or even reduce the need for pharmaceutical interventions, offering a more straightforward and potentially side-effect-free option for patients.

What evidence suggests that this wearable Focal Vibration Therapy is effective for improving upper extremity function in multiple sclerosis?

Research shows that wearable Focal Vibration Therapy (FVT), which participants in this trial will receive, might help people with multiple sclerosis (MS) move better and feel less muscle stiffness. Studies have found that FVT can improve walking and movement in people with MS, suggesting it might also aid upper body use. Early evidence indicates it can reduce muscle tightness and weakness, making it easier for patients to use their arms and hands. Although more research is needed, these initial findings are promising for improving the quality of life for those with MS.15678

Who Is on the Research Team?

HW

Hongwu Wang

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for adults with relapsing-remitting Multiple Sclerosis who have trouble with arm functions. It's a small study to see if wearing a vibration device on the arm helps improve movement and strength.

Inclusion Criteria

I experience issues with my arm or hand, such as weakness, stiffness, or pain.
I am over 18 years old.
I have been diagnosed with relapsing-remitting MS.
See 6 more

Exclusion Criteria

Evidence of cognitive impairment that could interfere with following instructions (Mini-Montreal Cognitive Assessment score (Mini-MoCA) < 12)
I don't have conditions that make vibration therapy unsafe for me.
I don't have severe nerve or mental health issues that could affect my arms.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-week Focal Vibration Therapy (FVT) program using MyovoltTM wearable devices applied to arm muscles

4 weeks
Home-based, monitored via MyoVolt app

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of motor function and usability

4 weeks
In-person assessments at week 4 and week 8

What Are the Treatments Tested in This Trial?

Interventions

  • Wearable Focal Vibration Therapy

Trial Overview

The study tests wearable Focal Vibration Therapy (FVT) using MyovoltTM devices on the arms of participants. Over four weeks, it will assess how feasible this therapy is at home and its potential benefits for arm function in MS patients.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Intervention groupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41007175/

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Feasibility and Preliminary Efficacy of Wearable Focal Vibration Therapy on Gait and Mobility in People with Multiple Sclerosis: A Pilot Study.

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Feasibility and Preliminary Efficacy of Wearable Focal Vibration Therapy on Gait and Mobility in People with Multiple Sclerosis: A Pilot Study. Bioengineering ...

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A wearable focal vibration device for providing vibration therapy to a patient includes a control module, a vibration module and a vibration sensor.