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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within stroke patients. vCR will be administered with a device called the Vibrotactile (VT) Brain Glove. vCR is expected to provide patients with a non-invasive therapy to aid in recovery from a stroke. This study will include a dedicated sham arm that will aid in understanding true treatment effects from vCR.

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 data supports the effectiveness of the treatment Vibrotactile Coordinated Reset for stroke patients?

Research suggests that vibrotactile feedback, which involves using vibrations to provide sensory information, can be a safe and helpful approach for improving balance and hand function in patients with neurological conditions, including stroke. Studies have shown that using sensory noise, like vibrations, can improve hand dexterity and strength in stroke survivors, indicating potential benefits for similar vibrotactile therapies. ^{1 2 3 4 5}

Is vibrotactile therapy safe for humans?

Vibrotactile therapy has been studied for safety in stroke survivors, with one study finding it generally safe for daily use over a month, although some mild adverse effects like worsened sensory scores were reported. Another review suggests it could be a safe approach for balance and gait rehabilitation in neurological conditions, but more high-quality studies are needed to confirm this. ^{1 2 6 7 8}

How is Vibrotactile Coordinated Reset treatment different from other stroke treatments?

Vibrotactile Coordinated Reset is unique because it uses vibrations to stimulate the sense of touch, which can help improve motor function and balance in stroke patients by enhancing sensory feedback and motor activation. This approach is different from traditional therapies as it integrates multisensory information and provides augmented feedback to promote recovery. ^{1 2 3 9 10}

Research Team

Peter Tass, MD, Ph.D

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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. Switzerland pubmed.ncbi.nlm.nih.gov

Vibrotactile-Based Rehabilitation on Balance and Gait in Patients with Neurological Diseases: A Systematic Review and Metanalysis. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

What is "usual care" in the rehabilitation of upper limb sensory loss after stroke? Results from a national audit and knowledge translation study. [2022]

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

Tactile Sensation Improves Following Motor Rehabilitation for Chronic Stroke: The VIGoROUS Randomized Controlled Trial. [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. Switzerland pubmed.ncbi.nlm.nih.gov

Usability Evaluation of a VibroTactile Feedback System in Stroke Subjects. [2022]

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

Sensory stimulation in acute stroke therapy. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Mirror Visual Feedback Combining Vibrotactile Stimulation Promotes Embodiment Perception: An Electroencephalogram (EEG) Pilot Study. [2020]

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

Restoration of Somatosensory Function by Pairing Vagus Nerve Stimulation with Tactile Rehabilitation. [2022]