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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a non-invasive treatment for early-stage Parkinson's disease symptoms using a device called the Stanford Glove. The treatment, Vibrotactile Coordinated Reset (vCR), applies vibrations to the fingertips to potentially disrupt abnormal brain activity, offering an alternative to traditional treatments like medication or surgery. The trial seeks participants with early-stage Parkinson's who are comfortable with technology and reside in the United States. Participants should be willing to pause Parkinson's medications during certain study visits. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research in non-invasive Parkinson's treatments.

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.

What prior data suggests that this device is safe for Parkinson's patients?

Research has shown that Vibrotactile Coordinated Reset (vCR) has been tested in people with Parkinson's disease to assess its safety and effectiveness. These studies found that vCR can help adjust abnormal brain rhythms associated with Parkinson's, potentially improving movement problems. vCR is non-invasive, meaning it doesn't involve surgery, which reduces the risk of side effects compared to treatments like deep brain stimulation that require surgery. Although specific side effects aren't detailed, the non-invasive nature of vCR suggests promising safety. Overall, studies indicate that vCR is generally well-tolerated, but more research is needed to fully understand its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Vibrotactile Coordinated Reset (vCR) is unique because it uses vibratory stimulation delivered to the fingertips in a specific pattern, which aims to disrupt abnormal brain synchrony associated with Parkinson's disease. Unlike traditional treatments like medications that primarily focus on supplementing dopamine or managing symptoms, vCR targets the brain's neural networks directly through a non-invasive method. Researchers are excited about this treatment because it offers a novel way to potentially rewire the brain's activity without the need for drugs or surgical interventions, presenting a promising alternative for managing symptoms of Parkinson's disease.

What evidence suggests that Vibrotactile Coordinated Reset is effective for Parkinson's Disease?

Research has shown that Vibrotactile Coordinated Reset (vCR) stimulation, which participants in this trial will receive, can help people with Parkinson's disease. Studies indicate that vCR can lead to lasting improvements in symptoms. For example, some research found that Parkinson's patients had better movement scores after using this method. Another study showed that even after stopping treatment, patients retained their motor skills. These findings suggest that vCR might be a promising non-invasive option for managing Parkinson's symptoms. ^{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

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]

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]

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]

Citations

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

Vibrotactile coordinated reset stimulation for the treatment ... Accordingly, pre-clinical studies in parkinsonian monkeys showed that CR-DBS delivered to the STN was significantly more effective, in fact causing a month-long ...

2. 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, ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06559098

Vibrotactile Coordinated Reset (vCR) for the Treatment of ... The purpose of this study is to test the efficacy of vibrotactile coordinated reset(vCR) stimulation on human subject participants with advanced stage ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5836884/

Coordinated reset vibrotactile stimulation shows prolonged ... Coordinated reset vibrotactile stimulation shows prolonged improvement in Parkinson's ... Outcomes included a blinded rating of the Unified Parkinson's Disease ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05504902

Vibrotactile Coordinated Reset for the Treatment of ... The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on advanced stage Parkinson's symptoms.

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

Clinical Efficacy and Dosing of Vibrotactile Coordinated ... A previous study has shown that vCR can desynchronize abnormal brain rhythms within the sensorimotor cortex of PD patients, corresponding to ...