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

20 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Vibrotactile Coordinated Reset Stimulation for Parkinson's Disease?

Research shows that Vibrotactile Coordinated Reset Stimulation (vCR) can reduce abnormal brain rhythms and improve motor symptoms in Parkinson's patients, with sustained relief after 3 months of daily treatment. Additionally, a study found that vCR can help with freezing of gait, a common issue in Parkinson's, by reducing episodes and improving mobility. ^{1 2 3 4 5}

Is the Stanford Glove for Parkinson's Disease safe for humans?

Research shows that the vibrotactile stimulation device, similar to the Stanford Glove, is safe and well tolerated in people with Parkinson's Disease. Studies found no significant safety concerns, and the device was effective in reducing tremor severity. ^{1 3 5 6 7}

How is the Stanford Glove treatment for Parkinson's Disease different from other treatments?

The Stanford Glove treatment uses vibrotactile coordinated reset stimulation (vCR), which is a non-invasive therapy that delivers gentle vibrations to the fingertips to reduce abnormal brain rhythms associated with Parkinson's Disease. Unlike traditional treatments that may involve medication or invasive procedures, vCR aims to desynchronize neural networks and provide long-lasting motor relief through daily use. ^{1 2 3 5 8}

What is the purpose of this trial?

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms of a more variable population. vCR will be administered with a device called the Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as Levodopa and or deep brain stimulation. Patients will be followed for two years.

Research Team

Peter Tass, MD, Ph.D

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Switzerland 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. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Coordinated Reset Vibrotactile Stimulation Induces Sustained Cumulative Benefits in Parkinson's Disease. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Daily Vibrotactile Stimulation Exhibits Equal or Greater Spasticity Relief Than Botulinum Toxin in Stroke. [2023]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Focused Vibrotactile Stimulation with Cueing Effect on Freezing of Gait in Parkinson's Disease: Two Case Reports. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Vibrotactile Coordinated Reset Stimulation for the Treatment of Neurological Diseases: Concepts and Device Specifications. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Tolerability of a Wearable, Vibrotactile Stimulation Device for Parkinson's Disease. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

An Acute Randomized Controlled Trial of Noninvasive Peripheral Nerve Stimulation in Essential Tremor. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

An untethered shoe with vibratory feedback for improving gait of Parkinson's patients: the PDShoe. [2020]