Vibrotactile Stimulation for Parkinson's Disease

Overseen By Ellyn Daly

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Neuro-psychiatric problems, Drug abuse, others

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

Compensation: Varies

Number of Visits: 6

Duration: 24 months

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new treatment called Vibrotactile Coordinated Reset stimulation (vCR) for people with early stage Parkinson's disease. The treatment uses a device called the Stanford Glove to send vibrations to the nervous system. It aims to provide a non-invasive alternative to common treatments like medication or surgery by helping the brain's nerve cells work better.

Will I have to stop taking my current medications?

The trial requires participants to feel comfortable going off Parkinson's disease-related medication during in-person study visits.

Is vibrotactile stimulation safe for humans?

Research shows that vibrotactile stimulation is generally safe and well tolerated in humans, with studies indicating no significant safety concerns when used for Parkinson's disease. ^{1 2 3 4 5}

How does the Vibrotactile Coordinated Reset treatment differ from other treatments for Parkinson's Disease?

Vibrotactile Coordinated Reset (vCR) is unique because it is a non-invasive treatment that uses gentle vibrations on the fingertips to reduce abnormal brain synchronization, which is a key issue in Parkinson's Disease. Unlike traditional treatments that often involve medication or invasive procedures, vCR aims to provide long-lasting relief from motor symptoms by 'unlearning' abnormal brain patterns through regular, non-invasive stimulation. ^{2 3 4 6 7}

What data supports the effectiveness of the treatment Vibrotactile Coordinated Reset for Parkinson's Disease?

Research shows that Vibrotactile Coordinated Reset (vCR) can reduce abnormal brain rhythms and improve motor symptoms in Parkinson's patients. Studies have demonstrated that vCR leads to sustained motor relief and reduces tremor severity, indicating its potential effectiveness as a non-invasive treatment. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 35-90 in the U.S. with early stage Parkinson's (Hoehn and Yahr stage 1). Participants must be comfortable stopping their Parkinson's medication during visits, able to use technology for virtual meetings, and have social support if needed.

Inclusion Criteria

I am okay with stopping my Parkinson's disease medication for study visits.

I have someone to help me when my condition worsens.

You have someone to help you if needed when you are not feeling well.

Exclusion Criteria

I have had brain surgery, but not just burr holes.

Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators

I have had brain surgery.

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 Stanford Glove

24 months

Regular visits at 6-month intervals

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Vibrotactile Coordinated Reset

Trial Overview The study tests Vibrotactile Coordinated Reset (vCR) using a device called vibrotactile axon Glove on early-stage Parkinson's symptoms. It offers a non-invasive treatment alternative, monitoring patients over two years.

How Is the Trial Designed?

Group I: Vibrotactile Coordinated Reset (vCR) Experimental Treatment 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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Coordinated reset stimulation (CRS) can effectively reduce abnormal brain synchronization associated with Parkinson's disease, as shown in pre-clinical and clinical studies involving parkinsonian monkeys and patients.

The study introduces noninvasive CRS methods using vibrotactile stimulation on fingertips, targeting various mechanoreceptors, which could provide a new avenue for therapeutic intervention in brain disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibrotactile Coordinated Reset Stimulation for the Treatment of Neurological Diseases: Concepts and Device Specifications. Tass, PA.[2020]

In two feasibility studies involving eight Parkinson's disease patients, both regular and noisy vibrotactile coordinated reset (vCR) stimulation significantly improved motor abilities without any reported side effects.

EEG recordings from one study indicated that noisy vCR therapy led to a significant reduction in high beta power in the sensorimotor cortex, suggesting it effectively modulates neuronal activity related to motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Coordinated Reset Vibrotactile Stimulation Induces Sustained Cumulative Benefits in Parkinson's Disease. Pfeifer, KJ., Kromer, JA., Cook, AJ., et al.[2023]

A novel vibrotactile stimulation device that delivers rhythmic stimuli to the sternum significantly reduced freezing of gait (FOG) episodes in two patients with Parkinson's disease, improving their mobility as measured by the Timed Up and Go test.

The combination of focused vibrotactile stimulation and cueing was effective in alleviating FOG symptoms, suggesting a potential new approach for managing this common issue in Parkinson's disease, though further studies are needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focused Vibrotactile Stimulation with Cueing Effect on Freezing of Gait in Parkinson's Disease: Two Case Reports. Tan, XS., Pierres, F., Dallman-Porter, A., et al.[2021]

A study involving 44 participants with Parkinson's disease found that a novel wearable vibrotactile stimulation device was safe and well tolerated, showing a moderate reduction in resting tremor severity (p < 0.001).

Both high amplitude patterned and low amplitude continuous vibration paradigms were effective in reducing tremor, with no significant difference in effectiveness between the two methods (p = 0.14).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of a Wearable, Vibrotactile Stimulation Device for Parkinson's Disease. Tabacof, L., Braren, S., Patterson, T., et al.[2021]

A new non-invasive treatment called vibrotactile coordinated reset (vCR) aims to improve motor and non-motor symptoms in Parkinson's disease (PD) patients by delivering gentle vibrations to the fingertips, with a 7-month study involving 30 participants to assess its efficacy.

The study will measure the effects of vCR on motor abilities using the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and other evaluations, with the goal of providing evidence for FDA clearance of this innovative therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Efficacy and Dosing of Vibrotactile Coordinated Reset Stimulation in Motor and Non-motor Symptoms of Parkinson's Disease: A Study Protocol. Pfeifer, KJ., Cook, AJ., Yankulova, JK., et al.[2023]

Citations

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

Vibrotactile Coordinated Reset Stimulation for the Treatment of Neurological Diseases: Concepts and Device Specifications. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Coordinated Reset Vibrotactile Stimulation Induces Sustained Cumulative Benefits in Parkinson's Disease. [2023]

3. Korea (South) pubmed.ncbi.nlm.nih.gov

Focused Vibrotactile Stimulation with Cueing Effect on Freezing of Gait in Parkinson's Disease: Two Case Reports. [2021]

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

Safety and Tolerability of a Wearable, Vibrotactile Stimulation Device for Parkinson's Disease. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Efficacy and Dosing of Vibrotactile Coordinated Reset Stimulation in Motor and Non-motor Symptoms of Parkinson's Disease: A Study Protocol. [2023]

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

Towards non-invasive peripheral stimulation as a treatment for Parkinson's disease gait. [2023]

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

Vibrotactile Feedback Alters Dynamics Of Static Postural Control In Persons With Parkinson's Disease But Not Older Adults At High Fall Risk. [2018]