Vibrotactile Therapy for Stroke

Overseen By Jessica Yankulova

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Botox, Baclofen

Disqualifiers: Psychiatric problems, Seizures, Drug abuse, others

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

Compensation: Varies

Number of Visits: 3

Duration: 8 months

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test a new therapy called Vibrotactile Coordinated Reset (vCR), which uses a device to send vibrations to the fingertips to improve movement skills after a stroke. The goal is to determine if this non-invasive approach aids stroke recovery. Participants are divided into two groups: one receives the active therapy, and the other receives a sham (inactive) treatment for comparison. This trial suits individuals who experienced a stroke more than six months ago, have some motor difficulties, and are not taking medications that affect balance. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research in stroke recovery.

Will I have to stop taking my current medications?

The trial requires that participants do not take medications that affect balance. If you are on such medications, you may need to stop them to participate.

What prior data suggests that the Vibrotactile Brain Glove is safe for stroke patients?

Research has shown that Vibrotactile Coordinated Reset (vCR) might be a safe and well-tolerated treatment. Previous studies have examined its use for conditions like Parkinson's disease and spinal cord injuries. These studies suggest that vCR, which uses vibrations on the fingertips to aid the brain, is non-invasive and medication-free, making it generally safe for patients. Significant reports of serious side effects have not emerged. This promising therapy could help stroke patients improve movement abilities without major risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Vibrotactile Coordinated Reset (vCR) because it offers a novel approach to stroke rehabilitation by using vibratory stimulation on the fingertips. Unlike traditional treatments that often focus on physical therapy and medication to aid recovery, vCR aims to disrupt abnormal brain activity patterns through specific vibration sequences. This approach is unique because it targets the brain's synchrony issues directly, potentially leading to improved motor function without the need for drugs or invasive procedures. The non-invasive nature of this technique, along with its potential to directly influence brain activity, makes it a promising frontier in stroke recovery.

What evidence suggests that the Vibrotactile Coordinated Reset is effective for stroke recovery?

Research shows that Vibrotactile Coordinated Reset (vCR) might improve movement in stroke patients. This trial will compare two groups: one receiving Active Vibrotactile Coordinated Reset, which uses gentle vibrations on the fingertips to potentially correct unusual brain activity after a stroke, and another receiving Sham Vibrotactile Coordinated Reset, which delivers an inactive vibration pattern. While specific data for stroke patients is still being gathered, results in other conditions like spinal cord injuries have been encouraging, with vCR helping with symptoms. Early findings from related studies suggest that this vibration method could offer a non-invasive way to support recovery. However, more focused research is needed to fully understand its effectiveness for stroke recovery. ^{1 2 3 5 6}

Who Is on the Research Team?

Peter Tass, MD, Ph.D

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 who've had a stroke at least 6 months ago, have some motor function left, and can mentally engage (score of ≥24 on a mental state exam). They shouldn't be on balance-affecting meds or have other major neurological issues, severe joint stiffness, recent spasticity treatments except bracing/splinting, or be pregnant/breastfeeding.

Inclusion Criteria

My disability level is moderate to moderately severe.

My mental state is clear and I scored at least 24 on a cognitive test.

I have difficulty moving or controlling my muscles.

Exclusion Criteria

I have had brain surgery or a device implanted for a neurological disorder.

I have significant stiffness in my joints.

Pregnancy, breastfeeding or wanting to become pregnant during the trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Vibrotactile Coordinated Reset stimulation using the Vibrotactile Brain Glove

8 months

Baseline, 3-month, 4-month, 7-month, and 8-month visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vibrotactile Coordinated Reset

Trial Overview The study tests Vibrotactile Coordinated Reset (vCR) therapy using the VT Brain Glove to improve motor skills in chronic stroke patients. Participants will receive either active vCR or a sham treatment without therapeutic effect to compare outcomes.

How Is the Trial Designed?

Group I: Active Vibrotactile Coordinated Reset (vCR) Active Control 1 Intervention

Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. A specific pattern of vibration to each fingertip is delivered which theoretically disrupts abnormal synchrony in the brain.

Group II: Sham Vibrotactile Coordinated Reset (vCR) Placebo Group 1 Intervention

Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. An inactive pattern of vibration to each fingertip is delivered which theoretically will not have the effects of active vCR.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

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]

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]

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]

Early sensory stimulation within the first 6 hours after an ischemic stroke may have significant effects on recovery, with preclinical studies showing both neuroprotective benefits and potential increases in infarct volumes by 30-50%.

Understanding the impact of acute sensory stimulation is crucial, as stroke patients often experience uncontrolled sensory inputs during transport and treatment, highlighting the need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory stimulation in acute stroke therapy. von Bornstädt, D., Gertz, K., Lagumersindez Denis, N., et al.[2023]

The Arm Usage Coach (AUC) system, which provides VibroTactile (VT) feedback to encourage arm movement in stroke patients, was found to be a feasible and accepted method for enhancing upper extremity use during daily activities.

Initially, most participants preferred acoustic or visual feedback, but after using the AUC, nine out of ten participants favored VT feedback, indicating its effectiveness in motivating arm use in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability Evaluation of a VibroTactile Feedback System in Stroke Subjects. Held, JP., Klaassen, B., van Beijnum, BF., et al.[2022]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05490277

Vibrotactile Coordinated Reset for the Treatment of Chronic ... The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within stroke patients.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05490277/vibrotactile-coordinated-reset-for-the-treatment-of-chronic-stroke

Vibrotactile Coordinated Reset for the Treatment of Chronic ... The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within stroke ...

3. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.758481/full

Clinical Efficacy and Dosing of Vibrotactile Coordinated ... In one patient, we planned a 1-month pause in stimulation after 6 months of therapy. Results showed no considerable differences in motor ability. Additionally, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8636796/

Clinical Efficacy and Dosing of Vibrotactile Coordinated ... In one patient, we planned a 1-month pause in stimulation after 6 months of therapy. Results showed no considerable differences in motor ability ...

5. withpower.com withpower.com/trial/phase-spinal-cord-injuries-2-2024-5ecd2

Vibrotactile Therapy for Spinal Cord Injury The purpose of our study is to evaluate vibrotactile Coordinated Reset (vCR) and its effects on spasticity symptoms in incomplete spinal cord injured ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8771098/

Vibrotactile coordinated reset stimulation for the treatment ... Furthermore, these results indicate that vCR may ultimately provide a safe and tolerable non-pharmacological and non-invasive treatment option for PD patients.