Stanford Glove for Parkinson's Disease

Overseen By Ellyn Daly

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must not be taking: Withdrawal-causing medications

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: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to managing Parkinson's disease symptoms using the Stanford Glove, a device that provides vibrotactile coordinated reset stimulation (vCR). The goal is to determine if this non-invasive method can effectively serve as an alternative to traditional treatments like medication or surgery. The trial is open to individuals in the U.S. who have Parkinson’s disease symptoms, are comfortable using technology, and can attend in-person visits without their usual Parkinson’s medications. Researchers will follow participants over two years to track any changes in their symptoms. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for Parkinson's disease.

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. If you are taking a medication that may cause significant withdrawal effects, you may not be eligible to participate.

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

Research has shown that Vibrotactile Coordinated Reset (vCR) stimulation is generally safe for people. Earlier studies found that short sessions using wearable devices were safe and well-tolerated, with most participants experiencing no serious side effects. This treatment uses gentle vibrations to help reduce symptoms, offering a non-invasive alternative to traditional treatments like medication or surgery. Current evidence suggests it is a promising and safe way to manage Parkinson's symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Vibrotactile Coordinated Reset Stimulation for Parkinson's disease because it offers a non-invasive way to potentially ease symptoms. Unlike standard treatments like medications that often target dopamine levels or surgical interventions, this method uses a wearable device to deliver precise vibrations to the skin, which could help reorganize brain activity. This approach might reduce tremors and improve movement without the side effects associated with drugs or the risks of surgery.

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

Research has shown that a treatment called Vibrotactile Coordinated Reset (vCR) stimulation, which participants in this trial will receive, might help alleviate Parkinson's disease symptoms. Studies have found that vCR can enhance movement skills in patients, with benefits persisting over time. In one study, even after stopping the treatment for a month, movement abilities did not significantly decline. Another study found that vCR led to lasting improvements in Parkinson's symptoms, as evaluated by experts. While more research is needed, these findings suggest that vCR could be a promising non-invasive option for managing Parkinson's symptoms. ^{4 6 7 8 9}

Who Is on the Research Team?

Peter Tass, MD, Ph.D

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for Parkinson's patients aged 35-92, at stages 2 to 4 of the disease, who are comfortable with technology and can attend virtual meetings. They must be fluent in English, live in the US, and be willing to temporarily stop their Parkinson's medication during study visits.

Inclusion Criteria

Fluent in English

Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.

I am between 35 and 92 years old.

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.

I have had brain surgery.

I have severe difficulty speaking or communicating.

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

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Vibrotactile Coordinated Reset Stimulation

Trial Overview The Stanford Glove is being tested as a non-invasive treatment option for Parkinson's. It uses Vibrotactile Coordinated Reset stimulation (vCR) which may help alleviate symptoms. Participants will use this device and be monitored over two years.

How Is the Trial Designed?

Group I: Stimulation Experimental Treatment 1 Intervention

Patients will be asked to stimulate using a non invasive vibrotactile device.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

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 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]

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]

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]

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]

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/PMC8636931/

Safety and Tolerability of a Wearable, Vibrotactile ... Conclusion: Short durations of vibrotactile stimulation delivered via wearable devices were safe and well tolerated and may attenuate resting ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05881460

Vibrotactile Coordinated Reset: a Non-invasive Treatment ... The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor function in people with Parkinson's disease ( ...

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

Clinical Efficacy and Dosing of Vibrotactile Coordinated ... Patients will receive stimulation for 4 h a day in 2-h blocks for 6 months followed by a 1-month pause in stimulation to assess long lasting ...

9. journals.lww.com journals.lww.com/nrronline/fulltext/2022/07000/vibrotactile_coordinated_reset_stimulation_for_the.23.aspx

Vibrotactile coordinated reset stimulation for the treatment ... Coordinated reset (CR) stimulation was computationally developed to cause an “unlearning” of pathologically persistent synchrony and synaptic connectivity.