Non-Invasive Vibration Therapy for Parkinson's Disease

Overseen By Kristina Pfeifer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Antidepressants, others

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 tests a new, non-invasive treatment called Vibrotactile Coordinated Reset (vCR) for individuals with advanced Parkinson's disease. The treatment involves a special glove that sends vibrations to the fingertips, aiming to improve symptoms without surgery or medication. Individuals experiencing Parkinson's symptoms who can manage being off certain medications might be suitable candidates. Participants should also be comfortable using technology such as computers and video calls. The study will monitor participants over two years to evaluate the treatment's effectiveness. As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for Parkinson's disease.

Will I have to stop taking my current medications?

The trial requires that you feel comfortable going off Parkinson's disease-related medication during in-person study visits and any medication that affects brain function or alters EEG activity before EEG recording. If you are taking a medication that may cause significant withdrawal effects, you may not be eligible to participate.

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

Research has shown that Vibrotactile Coordinated Reset (vCR) might be safe for people with Parkinson's disease. Studies have found that vCR can improve symptoms over the long term without causing significant side effects. In one study, five participants handled the treatment well, reporting no major problems or discomfort.

Another study found that even after a break from the treatment, participants experienced no major changes in movement abilities, suggesting that the treatment does not cause harm over time. These findings suggest that vCR is a well-tolerated option for managing advanced Parkinson's symptoms. However, it is always important to consult healthcare professionals before joining any clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Vibrotactile Coordinated Reset (vCR) is unique because it takes a non-invasive approach to treating Parkinson's disease by using vibratory stimulation on the fingertips. Unlike traditional Parkinson's treatments that often involve medication like Levodopa to manage symptoms, vCR aims to disrupt abnormal brain patterns through specific vibration patterns. This new mechanism of action could offer a fresh way to address the neurological aspects of the disease without the side effects associated with drugs. Researchers are excited about vCR because it represents a potential shift towards non-drug therapies in Parkinson's care, which could improve quality of life for patients with fewer complications.

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

Research has shown that Vibrotactile Coordinated Reset (vCR) stimulation, which participants in this trial will receive, can help alleviate Parkinson's disease symptoms by interrupting unusual brain activity. Studies have found that this method can lead to long-lasting improvements in movement issues common in Parkinson's. Some patients maintained stable movement abilities even after stopping treatment, indicating lasting benefits. In Parkinson's, reducing certain brain activity is linked to better movement, and vCR has helped achieve this positive change. Overall, these findings suggest vCR could be a promising non-invasive way to manage Parkinson's symptoms. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

This trial is for people aged 35-90 with advanced Parkinson's Disease (stages 2 to 4), who are comfortable with technology and can manage without certain brain function medications during EEG recordings. They must not be pregnant, involved in other trials recently, have a history of significant brain surgery or severe psychiatric issues, or substance abuse problems.

Inclusion Criteria

Fluent in English

Appropriate social support if required during an off state

I am willing to stop my brain-related medication before an EEG test.

Exclusion Criteria

Any current drug or alcohol abuse

I have had brain surgery.

Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies

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 CR Glove

24 months

Regular visits at Baseline, 6 months, 12 months, 18 months, 24 months

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 Vibrotactile Coordinated Reset stimulation using the vibrotactile axon Glove on Parkinson's symptoms. It offers a non-invasive treatment alternative to levodopa or deep brain stimulation and monitors 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 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]

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 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]

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 ...

Increases in Beta band PSD are associated with motor impairment in Parkinson's disease, while decreases in the beta band are associated with motor improvement.

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 disease - PMC.

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.