Vibrotactile Stimulation for Parkinson's Disease

Overseen By Jessica K Yankulova

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Neuro-psychiatric problems, Drug abuse, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called Vibrotactile Coordinated Reset (vCR) for people with Parkinson's disease who have already undergone surgery but still face challenges. The treatment uses a device known as the Stanford Glove to send gentle vibrations to the fingertips, aiming to improve symptoms without more invasive options like deep brain stimulation. People with Parkinson's who have had surgery other than deep brain stimulation, are comfortable with technology, and live in the U.S. might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research and potentially improve quality of life.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since the study involves a non-invasive treatment, it might not require stopping other medications. Please consult with the trial coordinators for specific guidance.

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

Research shows that Vibrotactile Coordinated Reset (vCR) is being explored for its potential to help people with Parkinson's disease. Earlier studies found that vCR can interrupt unusual brain activity in Parkinson's patients, which may lead to better movement control.

Regarding safety, there's positive news. The treatment uses a device called the Stanford Glove, which sends vibrations to the fingertips. This method is non-invasive, meaning it doesn't involve surgery, so it is less likely to cause serious side effects.

While detailed safety information is still being collected, the non-invasive nature of vCR suggests it might be well-tolerated. Previous studies haven't reported major problems, making it a promising option for those seeking alternatives to traditional treatments. However, discussing potential risks and benefits with a healthcare provider before joining a clinical trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Vibrotactile Coordinated Reset (vCR) for Parkinson's Disease because it introduces a non-invasive approach that targets brain activity through vibratory stimulation of the fingertips. Unlike traditional treatments like medications that adjust dopamine levels or deep brain stimulation which involves surgery, vCR aims to disrupt abnormal brain synchrony using specific vibration patterns. This innovative technique could offer a new way to manage symptoms without the side effects associated with more invasive or pharmacological options.

What evidence suggests that this device is effective for Parkinson's Disease?

Research has shown that Vibrotactile Coordinated Reset (vCR), the treatment under study in this trial, might help improve symptoms in people with Parkinson's disease. One study demonstrated that vCR led to long-lasting improvements in movement problems, as measured by a standard Parkinson's test. Another study found that even after stopping the treatment for a month, there was no major decline in movement abilities, suggesting the benefits might last. Research on monkeys with Parkinson's-like symptoms also showed that similar treatment greatly reduced symptoms for a long time. These findings suggest that vCR could be a promising non-invasive way to manage Parkinson's symptoms. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for Parkinson's Disease patients aged 35-90 in the U.S. who've had surgery (not DBS) for their condition, are comfortable with technology, and have support during off states. Excluded are those with severe psychiatric issues, substance abuse, recent or concurrent trial participation, pregnancy intentions, communication difficulties due to speech problems, excessive drooling or fingertip sensory abnormalities.

Inclusion Criteria

I am between 35 and 92 years old.

I have been diagnosed with Parkinson's disease.

Lives in the United States

Exclusion Criteria

My Parkinson's disease symptoms are so severe that I am confined to bed.

I feel unusual sensations in my fingertips.

Pregnancy, breast-feeding or wanting to become pregnant

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 as per study protocol

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 a non-invasive treatment called Vibrotactile Coordinated Reset (vCR), delivered through a device named vibrotactile axon Glove. It aims to offer an alternative to levodopa or deep brain stimulation for post-surgery PD patients. Participants will be monitored over two years to assess vCR's effectiveness.

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 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]

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 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]

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]

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]

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 ...