Vibrotactile Therapy for Parkinson's Disease

Overseen By Jessica Yankulova

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Pregnancy, Medical device, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Vibrotactile Coordinated Reset (vCR) to determine its effectiveness in relieving Parkinson's Disease symptoms. The Stanford Glove device will deliver vCR, providing a non-invasive alternative to common treatments like medication or brain surgery. Participants will receive either the active vCR or a sham (inactive) version to compare results. Individuals who have had Parkinson's for some time and can communicate in English may qualify. As an unphased trial, this study presents a unique opportunity to explore innovative treatment options for Parkinson's Disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.

What prior data suggests that the Stanford Glove is safe for Parkinson's patients?

Research has shown that Vibrotactile Coordinated Reset stimulation (vCR), used in the Stanford Glove, is generally safe and well tolerated by people with Parkinson's Disease. Studies indicate that participants have not experienced significant side effects when using similar devices. This suggests that the Stanford Glove might offer a comfortable and non-invasive way to help manage Parkinson's symptoms. Consulting with a healthcare provider for personalized advice is always recommended. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Vibrotactile Therapy using the Stanford Glove for Parkinson's Disease because it offers a novel, non-invasive approach that could complement or even enhance existing treatments like medications and deep brain stimulation. Unlike traditional methods that primarily focus on chemical or surgical interventions, the Stanford Glove uses vibrations to potentially improve motor function by stimulating sensory pathways in the brain. This innovative technique may provide a more accessible and flexible treatment option, allowing patients to perform the therapy at home and integrate it into their daily routines.

What evidence suggests that the Stanford Glove is effective for Parkinson's Disease?

Research shows that the Stanford Glove uses a method called Vibrotactile Coordinated Reset (vCR) to assist people with Parkinson's disease. Early studies found that this vibrating glove can correct mixed-up brain signals, enhancing movement skills in those with Parkinson's. In this trial, participants will join either an active stimulation group, receiving the Stanford Glove with vCR, or a sham stimulation group. Other studies have shown that vCR can reduce unusual brain rhythms linked to Parkinson's symptoms. Overall, evidence suggests that the Stanford Glove could be a promising non-invasive treatment option for improving movement in people with Parkinson's. ^{3 6 7 8 9}

Who Is on the Research Team?

Vivek Buch, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Parkinson's Disease who can understand and agree to the study rules. They must have a certain level of motor impairment and not be in other trials, pregnant, or have sensory issues in their fingers or implanted medical devices.

Inclusion Criteria

My Parkinson's disease causes significant movement problems.

Fluent in English

I have been diagnosed with Parkinson's Disease.

Exclusion Criteria

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

Pregnancy, breast-feeding or wanting to become pregnant

I feel unusual sensations in my fingertips.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either active or sham vibrotactile coordinated reset stimulation using the Stanford Glove at home for the first month, followed by a reduced daily duration for the remainder of the treatment period

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 months

What Are the Treatments Tested in This Trial?

Interventions

• Stanford Glove

Trial Overview The study tests the Stanford Glove delivering Vibrotactile Coordinated Reset stimulation (vCR) as a non-invasive treatment option for Parkinson's symptoms. Participants will use this device and be monitored over a period of 14 months.

How Is the Trial Designed?

Group I: Active stimulation Active Control 1 Intervention

Participants will receive active stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR

Group II: Sham Stimulation Placebo Group 1 Intervention

Participants will receive sham stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR

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]

The VibroTactile Stimulation (VTS) Glove significantly reduced spastic hypertonia in patients with chronic stroke, showing clinically meaningful improvements in spasticity scores after 8 weeks of use and even 4 weeks after stopping the intervention.

For patients who were also receiving Botulinum toxin (BTX-A), over half experienced greater symptom relief with the VTS Glove compared to their previous BTX-A treatment, indicating that the VTS Glove could be an effective alternative or complement to traditional spasticity treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Vibrotactile Stimulation Exhibits Equal or Greater Spasticity Relief Than Botulinum Toxin in Stroke. Seim, C., Chen, B., Han, C., et al.[2023]

The PDShoe is a new vibratory feedback device designed to help improve gait in individuals with Parkinson's disease by providing adjustable vibratory cues during daily activities.

A preliminary evaluation with four Parkinson's disease patients and two healthy subjects demonstrated the usability of the PDShoe, indicating its potential for enhancing mobility in PD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An untethered shoe with vibratory feedback for improving gait of Parkinson's patients: the PDShoe. Winfree, KN., Pretzer-Aboff, I., Hilgart, D., et al.[2020]

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]

Vibrotactile Feedback (VF) using a portable device did not significantly improve conversational vocal intensity in real-life settings for individuals with Parkinson's disease, based on a study involving 8 participants over 4 weeks.

There was no notable difference in vocal intensity between VF combined with Lee Silverman Voice Treatment (LSVT LOUD®) and VF alone, indicating that both treatments may have limited effectiveness in enhancing vocal intensity for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conversational Vocal Intensity in Parkinson's Disease: Treatment and Environmental Comparisons. Konnai, R., Van Harn, M., Silbergleit, A.[2023]

Citations

1. stanmed.stanford.edu stanmed.stanford.edu/vibrating-glove-reorganize-neurons-parkinsons/

Can a vibrating glove treatment relieve Parkinson's symptoms? Early research shows that wearing a vibrating glove can reorganize misfiring signals in the brain and could relieve Parkinson's symptoms.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8055937/

Coordinated Reset Vibrotactile Stimulation Induces Sustained ... Results. Clinically, in both studies, we observed significantly improved motor ability. EEG recordings observed from study 1 indicated a ...

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34867742/

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 ...

5. withpower.com withpower.com/trial/phase-parkinson-disease-11-2023-fcf68

Stanford Glove for Parkinson's Disease · Info for Participants Research shows that Vibrotactile Coordinated Reset Stimulation (vCR) can reduce abnormal brain rhythms and improve motor symptoms in Parkinson's patients, with ...

6. 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.

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

Vibrotactile coordinated reset stimulation for the treatment ... However, the overall effects of, e.g., whole-body vibration therapy on PD turned out to be limited and somewhat inconsistent (Dincher et al., 2019). To leverage ...

8. stanfordhealthcare.org stanfordhealthcare.org/trials/v/NCT05545826.html

A Treatment for Early Stage Parkinson's Disease The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on early stage Parkinson's symptoms.

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

Coordinated reset vibrotactile stimulation shows prolonged ... One subject, who was on medication during stimulation, also demonstrated long‐term improvement in gait asymmetry and arrhythmicity. No significant effect was ...