Tactile Stimulation for Stroke

Overseen By Netta Gurari, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Must not be taking: Antispastic injections

Disqualifiers: Minors, Pregnant, Prisoners, others

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

Compensation: Varies

Number of Visits: 1

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have used antispastic injections in the past six months, you cannot participate.

What data supports the effectiveness of the treatment Tactile Stimulation for Stroke?

Research shows that tactile and somatosensory stimulation can improve tactile sensation and motor function in stroke patients. For example, one study found that about one-third of individuals with chronic stroke experienced sustained improvements in tactile sensation after motor rehabilitation, and another study showed that somatosensory stimulation enhanced motor function in patients with chronic strokes. ^{1 2 3 4 5}

Is tactile stimulation safe for stroke patients?

Tactile stimulation, such as using a wrist-worn device, has been tested for safety in stroke survivors. In a study, some participants experienced mild side effects like worsened sensory scores, but these were not more common during real stimulation compared to a sham (fake) stimulation. Overall, the study found that daily use of the device for a month is safe for chronic stroke survivors. ^{6 7 8 9 10}

How does the tactile stimulation treatment for stroke differ from other treatments?

Tactile stimulation for stroke is unique because it uses sensory feedback (like touch and vibration) to enhance the sense of touch and improve motor function, which is different from traditional motor rehabilitation that may not focus on sensory feedback. This approach can be used even when mobility issues prevent direct self-touch, making it a novel option for stroke recovery. ^{1 9 11 12 13}

What is the purpose of this trial?

Quantify the flow of a tactile signal from the stimulus at the finger at the peripheral nervous system (PNS), to the central nervous system (CNS), and to cognitive perception at the brain in young adults (Aim 1) and individuals with and without stroke (Aim 2).

Research Team

Netta Gurari, PhD

Principal Investigator

Virginia Polytechnic Institute and State University

Eligibility Criteria

This trial is for right-handed young adults aged 18-23 without musculoskeletal or neurological conditions, and individuals who have had a single stroke incident with a unilateral lesion, are in the chronic phase (>1 year post-stroke), and were over 18 at stroke onset. Participants must be able to give informed consent.

Inclusion Criteria

Right-hand dominance for participants who are neurotypical

I can give informed consent despite having speech difficulties.

I do not have any muscle or nerve conditions.

Exclusion Criteria

I have had a stroke and received injections for muscle stiffness in the last 6 months.

My stroke was caused by brain surgery.

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Evaluation

Participants undergo a one-session protocol to measure brain activation, conscious detection threshold, and peripheral nerve function using tactile stimuli

2 hours

1 visit (in-person)

Follow-up

Participants are monitored for any immediate effects post-evaluation

1 week

Treatment Details

Interventions

• Tactile Stimulation

Trial Overview The study measures how touch signals travel from the finger through the nervous system to the brain in both healthy young adults and those who have experienced a stroke. It aims to understand this process in typical conditions as well as after a stroke.

Participant Groups

Group I: Stimulus magnitude Experimental Treatment 1 Intervention

Differing levels of tactile stimulus will be applied

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Findings from Research

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 of 55 adults with moderate-to-severe upper limb hemiparesis, active somatosensory stimulation combined with motor training significantly improved motor function outcomes compared to sham stimulation, as measured by the Wolf Motor Function Test and Action Research Arm Test.

While the active stimulation showed benefits in motor function, it did not significantly affect the Fugl-Meyer Assessment, and the clinical relevance of the observed differences remains to be determined, suggesting further research is needed to explore its impact on overall disability and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nerve Stimulation Enhances Task-Oriented Training for Moderate-to-Severe Hemiparesis 3-12 Months After Stroke: A Randomized Trial. Carrico, C., Westgate, PM., Salmon Powell, E., et al.[2019]

In a study involving nine chronic subcortical stroke patients, somatosensory stimulation (synchronous peripheral nerve stimulation) significantly improved hand function, reducing the time to complete the Jebsen-Taylor Hand Function Test by 10% compared to no stimulation.

The improvement in hand function was linked to a reduction in GABAergic inhibition in the motor cortex, suggesting that somatosensory stimulation may enhance motor training by modulating specific neural pathways.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Somatosensory stimulation enhances the effects of training functional hand tasks in patients with chronic stroke. Celnik, P., Hummel, F., Harris-Love, M., et al.[2022]

A new somatosensory retraining program for stroke patients showed significant improvements in tactile and proprioceptive discrimination, with seven out of eight tactile measures and all four proprioceptive measures demonstrating positive changes after treatment.

The improvements were clinically significant, with the affected hand's discrimination abilities becoming comparable to the unaffected hand, and these benefits were maintained during follow-up assessments conducted 3 to 5 months later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensory loss in stroke patients: effective training of tactile and proprioceptive discrimination. Carey, LM., Matyas, TA., Oke, LE.[2022]

In a study involving 11 stroke patients with cortical involvement, median nerve stimulation (MNS) significantly improved hand motor function compared to control stimulation, indicating its efficacy as a rehabilitation tool.

Patients who received MNS not only showed immediate improvements but also maintained these benefits 30 days later, suggesting that somatosensory stimulation can help consolidate motor training effects in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of somatosensory stimulation on motor function in chronic cortico-subcortical strokes. Conforto, AB., Cohen, LG., dos Santos, RL., et al.[2018]

The integration of haptic cues, using a haptic cane and vibrotactile feedback, significantly improved gait symmetry and increased muscle activity in the paretic leg of ten post-stroke subjects during walking trials, particularly at preferred and increased gait speeds.

Participants were able to maintain trunk balance while walking faster, with notable improvements in temporal stance symmetry and muscle activation patterns, suggesting that this combined cue system could enhance rehabilitation outcomes for individuals with unilateral hemiparetic stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effects of delivering integrated kinesthetic and tactile cues to individuals with unilateral hemiparetic stroke during overground walking. Afzal, MR., Pyo, S., Oh, MK., et al.[2019]

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 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]

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]

Stroke survivors with sensory deficits require significantly higher electrocutaneous stimulation currents (40% more) to perceive tactile stimuli on their affected hand compared to their unaffected hand.

For reliable perception of changes in stimulation intensity, a 140% increase in current is necessary on the paretic hand, indicating that traditional sensory assessments may not accurately reflect the effectiveness of electrocutaneous feedback in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impaired Discrimination of Electrocutaneous Stimulation in the Paretic Hand of Stroke Survivors. Citterman, AR., Stewart, AE., Urban, RJ., et al.[2023]

The case of patient NG demonstrates that a self-touch rubber-hand paradigm can effectively enhance tactile sensation in stroke patients who have mobility issues, allowing them to perceive touch on their affected limb.

Using this self-touch approach, NG was able to detect all stimulations on her prosthetic limb, while she missed one-third of stimulations when not involved, indicating that this method can reveal residual sensory capabilities post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new method for assessing self-touch enhancement of the foot in stroke patients with mobility problems. White, RC., Aimola Davies, AM.[2017]

A six-week intervention using a feedback-type tactile discrimination system significantly improved sensorimotor function in the left hand of a male stroke patient, enhancing deep sensation and movement quality.

The use of real-time vibration feedback during tasks like peg manipulation and material identification led to reorganization of sensorimotor areas in the brain, suggesting this method could be an effective rehabilitation strategy for hand dysfunction after a stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Intervention Effectiveness of Sensory Compensatory Training with Tactile Discrimination Feedback on Sensorimotor Dysfunction of the Hand after Stroke. Kitai, K., Odagiri, M., Yamauchi, R., et al.[2021]

The prototype hand trainer developed for post-stroke rehabilitation is safe, easy to use, and accommodates various hand sizes, making it accessible for a wide range of patients.

This device enhances recovery by providing rich sensory feedback through haptic rendering, combined with a rehabilitation game that incorporates diverse haptic elements to promote sensorimotor training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards Unsupervised Rehabilitation: Development of a Portable Compliant Device for Sensorimotor Hand Rehabilitation. Van Damme, N., Ratz, R., Marchal-Crespo, L.[2022]

References

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

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

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

Nerve Stimulation Enhances Task-Oriented Training for Moderate-to-Severe Hemiparesis 3-12 Months After Stroke: A Randomized Trial. [2019]

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

Somatosensory stimulation enhances the effects of training functional hand tasks in patients with chronic stroke. [2022]

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

Sensory loss in stroke patients: effective training of tactile and proprioceptive discrimination. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Effects of somatosensory stimulation on motor function in chronic cortico-subcortical strokes. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Evaluating the effects of delivering integrated kinesthetic and tactile cues to individuals with unilateral hemiparetic stroke during overground walking. [2019]

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

Sensory stimulation in acute stroke therapy. [2023]

8. 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]

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

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

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

Impaired Discrimination of Electrocutaneous Stimulation in the Paretic Hand of Stroke Survivors. [2023]

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

A new method for assessing self-touch enhancement of the foot in stroke patients with mobility problems. [2017]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of Intervention Effectiveness of Sensory Compensatory Training with Tactile Discrimination Feedback on Sensorimotor Dysfunction of the Hand after Stroke. [2021]

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

Towards Unsupervised Rehabilitation: Development of a Portable Compliant Device for Sensorimotor Hand Rehabilitation. [2022]