25 Participants NeededMy employer runs this trial

Vibrotactile Stimulation for Muscle Spasticity

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Weill Medical College of Cornell University
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 explores whether Vibrotactile Stimulation (VTS), a device that gently vibrates, can help individuals with lower limb spasticity (muscle stiffness) improve mobility and increase walking speed. Researchers aim to identify the optimal body locations for VTS application and determine its effectiveness in easing walking. Participants will use the VTS device during short sessions both at rest and while walking, and they will track their experiences. This trial may suit individuals who have experienced muscle stiffness for at least six months due to a neurological condition and can stand with or without assistance. As an unphased trial, it offers a unique opportunity to contribute to pioneering research that could enhance mobility solutions for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but if you are on medications for muscle relaxation, your regimen should be stable. If you are receiving other treatments like physiotherapy, they should have started more than 4 weeks before the trial and remain consistent.

What prior data suggests that this device is safe for use in people with lower limb spasticity?

Research has shown that Vibrotactile Stimulation (VTS) is generally safe and easy to use. Studies have found that short-term use of VTS with wearable devices does not cause harm and feels comfortable. No reports of serious side effects or health problems from VTS have emerged. This makes it a safe choice for those looking to reduce muscle stiffness and improve movement. However, users should monitor for any personal discomfort or issues while using the device.12345

Why are researchers excited about this trial?

Researchers are excited about vibrotactile stimulation (VTS) for muscle spasticity because it offers a non-invasive approach that could provide immediate relief. While most treatments for muscle spasticity, like oral medications or injections, often come with side effects or require time to take effect, VTS uses gentle vibrations to target specific muscles and might show benefits within days. This technique could be especially promising for improving mobility and comfort without the drawbacks of traditional therapies. Additionally, VTS's potential to be used both during rest and active movement offers flexible treatment options tailored to individual needs.

What evidence suggests that Vibrotactile Stimulation is effective for reducing muscle spasticity?

Research has shown that Vibrotactile Stimulation (VTS) can greatly reduce muscle stiffness. Studies have found that VTS relieves stiffness and high muscle tone for many people, even those who have tried other treatments like BTX-A. This type of stimulation decreases unwanted muscle spasms in various conditions. For example, VTS effectively reduces neck pain in people with cervical dystonia, a condition that causes neck muscle spasms. Overall, VTS shows promise for improving movement and reducing stiffness, making it a potential option for managing muscle stiffness. Participants in this trial will experience different applications of VTS, including static and dynamic use, to further explore its effectiveness.13467

Who Is on the Research Team?

JS

Joan Stilling, M.D., M.S.

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for adults with muscle stiffness in the leg due to a neurological condition (like stroke) that started at least 6 months ago. Participants must be able to stand or lie down, have moderate spasticity, and be able to follow study instructions. Recent botox treatment, surgery for spasticity, or unstable health conditions will exclude participation.

Inclusion Criteria

I can understand and follow the study instructions.
It has been at least 6 months since my diagnosis that caused spasticity.
My ankle muscle tightness is moderate or less.
See 1 more

Exclusion Criteria

I have had Botulinum Toxin treatment in my affected limb within the last 4 months.
I do not have any serious or uncontrolled illnesses that could affect my participation.
I have had surgery to treat spasticity in my affected leg.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

0 to 1 week

VTS Neurophysiological Mechanism

Participants use the VTS device for three 15-minute sessions at different anatomical locations to assess neurophysiological mechanisms.

1 day
1 visit (in-person)

VTS Static and Dynamic Use

Participants use the VTS device for 60 minutes daily for three consecutive days in static and dynamic contexts, with a 1-week washout period between.

3 weeks
6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Vibrotactile Stimulation

Trial Overview

The study tests different ways of using a vibrotactile stimulation (VTS) device on various body parts to see if it can reduce leg muscle stiffness and improve walking speed. Participants use the VTS device during lab sessions and at home while resting or walking.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: VTS Static Use, then Dynamic Use (Aim 2)Experimental Treatment1 Intervention
Group II: VTS Neurophysiological Mechanism (Aim 1)Experimental Treatment1 Intervention
Group III: VTS Dynamic Use, then Static Use (Aim 2)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials
394
Recruited
404,000+

Citations

Daily Vibrotactile Stimulation Exhibits Equal or Greater ...

Daily stimulation from the VTS Glove provides relief of spasticity and hypertonia. For more than half of the participants who had regularly used BTX-A, the VTS ...

Daily vibrotactile stimulation from a wearable device exhibits ...

Conclusions: Daily stimulation from the VTS Glove provides relief of spasticity and hypertonia. For more than half of participants who had ...

Trial to Test the Effectiveness of Vibrotactile Stimulation for ...

The goal of this clinical trial is to find out if Vibrotactile Stimulation (VTS) can help improve mobility and reduce spasticity (muscle stiffness) in people ...

Relief of post-stroke spasticity with acute vibrotactile ...

Cutaneous vibrotactile stimulation of the hand provides significant reductions in spastic hypertonia, compared to muscle stimulation.

Relief of post-stroke spasticity with acute vibrotactile stimulation

Cutaneous vibrotactile stimulation of the hand provides significant reductions in spastic hypertonia, compared to muscle stimulation.

Daily Vibrotactile Stimulation Exhibits Equal or Greater ...

The VTS Glove was associated with greater average improvement in spasticity and hypertonia than Botox injection.

Vibrotactile Stimulation for Muscle Spasticity

The goal of this clinical trial is to find out if Vibrotactile Stimulation (VTS) can help improve mobility and reduce spasticity (muscle ...