Vibrotactile Stimulation for Stroke Recovery

Overseen By Kimberly D Bassindale, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marquette University

Must not be taking: Aminoglycosides, Curare-like agents

Disqualifiers: Bleeding disorder, Epilepsy, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain antibiotics or agents that affect neuromuscular function.

What data supports the effectiveness of the treatment Vibrotactile stimulation for stroke recovery?

Research shows that using mechanical vibration, similar to vibrotactile stimulation, can improve hand motor function in stroke survivors by enhancing sensory input. Additionally, motor rehabilitation programs that include tactile elements have been found to improve tactile sensation in individuals with chronic stroke, suggesting potential benefits for recovery. ^{1 2 3 4 5}

Is vibrotactile stimulation safe for humans?

Research shows that using vibrotactile stimulation devices, like the TheraBracelet, is generally safe for stroke survivors, with only mild side effects such as worsened sensory scores in some cases. Most participants did not experience significant adverse effects, indicating that this type of stimulation is safe for prolonged use. ^{6 7 8 9 10}

How is the treatment Vibrotactile Stimulation unique for stroke recovery?

Vibrotactile Stimulation (VTS) is unique because it uses mechanical vibrations to stimulate the affected limb, which can improve hand function and reduce muscle tightness in stroke survivors. Unlike traditional therapies, VTS can be delivered through a wearable device like the VTS Glove, making it suitable for both clinical and home use. ^{1 4 7 8 10}

What is the purpose of this trial?

Supplementing or augmenting sensory information to those who have lost proprioception after stroke could help improve functional control of the arm. Thirty subjects will be recruited to a single site to evaluate the ability of supplemental kinesthetic feedback (a form of vibrotactile stimulation) to improve motor function. Participants will be tested in performing reaching movements as well as more functional tasks such as simulated drinking from a glass

Research Team

Robert A Scheidt, PhD

Principal Investigator

Marquette University

Eligibility Criteria

This trial is for stroke survivors with mild-to-moderate arm impairment, who can feel touch in the affected arm or thigh and have a minimal ability to extend their wrist. They must be at least 6 months post-stroke from an MCA event, able to consent and follow instructions, and have specific proprioceptive deficits. People with bleeding disorders, muscle diseases like ALS or myasthenia gravis, epilepsy, severe psychiatric conditions, pacemakers or significant heart issues cannot join.

Inclusion Criteria

I had a stroke but can still stabilize and grip objects.

I can feel touch in my arm or thigh on the same side as my lesion.

I can slightly bend my wrist upwards.

Exclusion Criteria

You have a history of other mental health conditions like schizophrenia.

I am not currently using drugs that affect muscle function.

I have a tumor inside my brain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Baseline Testing

Participants complete baseline tests of cognitive performance and sensorimotor impairment

3 days

3 visits (in-person)

Training

Participants undergo 20 sessions of training with supplemental kinesthetic feedback to improve motor control

20 days

20 visits (in-person)

Post-Training Assessment

Participants are re-tested on their capability to use a 3-DOF vibrotactile display for reach-to-grasp actions

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after training

4 weeks

Treatment Details

Interventions

• Vibrotactile stimulation

Trial Overview The study tests if vibrotactile stimulation—a type of sensory feedback—can help improve arm function after stroke. Thirty participants will try this method while doing tasks like reaching out or simulating drinking from a glass to see if it enhances motor control.

Participant Groups

Group I: Stroke Cohort - Whole Task Training Experimental Treatment 1 Intervention

Aim2 intervention: Vibrotactile stimulation. Training on only the more complex reaching task using vibrotactile feedback to guide performance

Group II: Stroke Cohort - Progressive Training Experimental Treatment 1 Intervention

Aim 1 intervention: Vibrotactile stimulation. Progressive training from simple to more complex reaching task using vibrotactile feedback to guide performance

Vibrotactile stimulation is already approved in United States, European Union for the following indications:

Approved in United States as Vibrotactile stimulation for:

• Rehabilitation of upper limb function in chronic stroke patients
• Relief of post-stroke spasticity

Approved in European Union as Vibrotactile stimulation for:

• Rehabilitation of upper limb function in chronic stroke patients
• Improvement of tactile perception and voluntary movement

Who Is Running the Clinical Trial?

Marquette University

Lead Sponsor

Trials

68

Recruited

202,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Medical College of Wisconsin

Collaborator

Trials

645

Recruited

1,180,000+

Findings from Research

The study involved 19 patients with chronic stroke and demonstrated that perturbation-based pinch task training significantly improved sensory function in the affected thumb, as measured by the Semmes-Weinstein monofilament test, immediately after training.

At the 12-week follow-up, the experimental group also showed significant improvements in the box and block test, indicating enhanced motor performance, while the control group had notable improvements in wrist and coordination scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a Novel Perturbation-Based Pinch Task Training on Sensorimotor Performance of Upper Extremity for Patients With Chronic Stroke: A Pilot Randomized Controlled Trial. Hsu, HY., Kuan, TS., Tsai, CL., et al.[2021]

In a study involving 167 adults with chronic stroke, all four upper limb motor rehabilitation programs led to similar improvements in tactile sensation, indicating that various rehabilitation methods can effectively enhance sensory recovery post-stroke.

Approximately one-third of participants experienced significant improvements in their tactile sensitivity, with those having poorer baseline sensation showing the greatest gains, suggesting that motor rehabilitation can be a valuable motivator for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tactile Sensation Improves Following Motor Rehabilitation for Chronic Stroke: The VIGoROUS Randomized Controlled Trial. Borstad, A., Nichols-Larsen, D., Uswatte, G., et al.[2022]

In a study involving 12 chronic stroke patients, noninvasive transcutaneous auricular vagus nerve stimulation (taVNS) combined with repetitive motor practice showed potential to improve sensory recovery, with 64% of participants regaining some sensation after treatment.

The results suggest that taVNS may enhance sensory recovery alongside motor rehabilitation, but further research with a larger group is needed to fully understand its effects on overall functional recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation with Upper Limb Repetitive Task Practice May Improve Sensory Recovery in Chronic Stroke. Baig, SS., Falidas, K., Laud, PJ., et al.[2020]

A pilot study demonstrated that applying subthreshold tactile sensory noise, like mechanical vibration, to the wrist significantly improved hand dexterity and pinch strength in chronic stroke survivors with sensory deficits.

The improvements in motor function suggest that this method may enhance neuronal connections in the sensoriomotor cortex, indicating potential for a simple wristband device to aid rehabilitation both in clinics and at home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of remote sensory noise on hand function post stroke. Seo, NJ., Kosmopoulos, ML., Enders, LR., et al.[2020]

Mobilization and Tactile Stimulation (MTS) can lead to improvements in upper limb motor function and impairment in chronic stroke survivors, even more than a year after their stroke, as shown in a study with 8 participants.

While all participants showed improvements in motor impairment, clinically significant enhancements in motor function were observed in half of the participants, with recovery often taking several days to manifest after starting the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of mobilization and tactile stimulation on chronic upper-limb sensorimotor dysfunction after stroke. Winter, JM., Crome, P., Sim, J., et al.[2022]

The TheraBracelet, a device providing low-level vibration, was found to be safe for chronic stroke survivors when worn for over 8 hours a day for 2 months, with fewer adverse events reported during the real stimulation month compared to the sham month.

Out of 25 participants, only 24% experienced mild adverse events, indicating that prolonged sensory stimulation does not significantly worsen hand function or sensation, suggesting it could be a beneficial tool for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors. Seo, NJ., Enders, LR., Fortune, A., et al.[2021]

In a study involving 16 chronic stroke survivors, the VTS Glove, which provides vibrotactile stimulation, significantly improved tactile perception and reduced spasticity in the affected hand over an 8-week period.

Participants using the VTS Glove also experienced increased voluntary finger flexion and improved range of motion in the elbow and shoulder, suggesting that wearable stimulation devices can enhance hand function in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wearable vibrotactile stimulation for upper extremity rehabilitation in chronic stroke: clinical feasibility trial using the VTS Glove. Seim, CE., Wolf, SL., Starner, TE.[2021]

The VibroTactile Stimulation (VTS) Glove significantly reduced spastic hypertonia in patients with chronic stroke, showing clinically meaningful improvements in spasticity scores after 8 weeks of use and even 4 weeks after stopping the intervention.

For patients who were also receiving Botulinum toxin (BTX-A), over half experienced greater symptom relief with the VTS Glove compared to their previous BTX-A treatment, indicating that the VTS Glove could be an effective alternative or complement to traditional spasticity treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Vibrotactile Stimulation Exhibits Equal or Greater Spasticity Relief Than Botulinum Toxin in Stroke. Seim, C., Chen, B., Han, C., et al.[2023]

The study developed a wireless wearable device that provides real-time vibrotactile feedback to assist in motor learning for bilateral reaching motions, which is particularly useful for at-home rehabilitation after a stroke.

Preliminary results from one hemiparetic stroke survivor and one healthy subject showed that vibrotactile feedback effectively improved motion symmetry and altered reaching trajectories, suggesting its potential for enhancing motor learning in both populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A wearable vibrotactile device for upper-limb bilateral motion training in stroke rehabilitation: A case study. Hung, CT., Croft, EA., Van der Loos, HF.[2020]

Vibrotactile stimulation can effectively enhance spatial discrimination and tactile intensity perception in both healthy individuals and amputees, with circular arrangements of vibrators yielding better results than linear ones.

The study found that the intensity and duration of vibrations significantly affect perception, with amputees achieving up to 91.67% accuracy using the optimal circular proportional arrangement, suggesting strong potential for improving sensory feedback in prosthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of vibration characteristics and vibror arrangement on the tactile perception of the upper arm in healthy subjects and upper limb amputees. Guemann, M., Bouvier, S., Halgand, C., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of a Novel Perturbation-Based Pinch Task Training on Sensorimotor Performance of Upper Extremity for Patients With Chronic Stroke: A Pilot Randomized Controlled Trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Tactile Sensation Improves Following Motor Rehabilitation for Chronic Stroke: The VIGoROUS Randomized Controlled Trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous Auricular Vagus Nerve Stimulation with Upper Limb Repetitive Task Practice May Improve Sensory Recovery in Chronic Stroke. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of remote sensory noise on hand function post stroke. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of mobilization and tactile stimulation on chronic upper-limb sensorimotor dysfunction after stroke. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Phase I Safety Trial: Extended Daily Peripheral Sensory Stimulation Using a Wrist-Worn Vibrator in Stroke Survivors. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Wearable vibrotactile stimulation for upper extremity rehabilitation in chronic stroke: clinical feasibility trial using the VTS Glove. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Daily Vibrotactile Stimulation Exhibits Equal or Greater Spasticity Relief Than Botulinum Toxin in Stroke. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

A wearable vibrotactile device for upper-limb bilateral motion training in stroke rehabilitation: A case study. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Effect of vibration characteristics and vibror arrangement on the tactile perception of the upper arm in healthy subjects and upper limb amputees. [2021]