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

34 Participants Needed

What You Need to Know Before You Apply

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. 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 14 months.

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.

Is vibrotactile therapy safe for humans?

Research shows that short durations of vibrotactile stimulation using wearable devices are safe and well tolerated in people with Parkinson's disease. ^{1 2 3 4 5}

How does the Stanford Glove treatment differ from other treatments for Parkinson's disease?

The Stanford Glove treatment is unique because it uses vibrotactile coordinated reset stimulation, which involves delivering gentle vibrations to the fingertips to desynchronize abnormal brain rhythms, potentially improving motor symptoms in Parkinson's disease. This non-invasive approach contrasts with traditional treatments like medication or deep brain stimulation, offering a novel way to address both motor and non-motor symptoms. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Stanford Glove for Parkinson's Disease?

Research shows that vibrotactile stimulation, like that used in the Stanford Glove, can reduce abnormal brain rhythms and improve motor symptoms in Parkinson's patients. Additionally, similar devices have been found to reduce resting tremor severity and improve gait, suggesting potential benefits for Parkinson's symptoms. ^{1 2 3 4 5}

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

Pregnancy, breast-feeding or wanting to become pregnant

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 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 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]

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]

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]

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]

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]

Citations

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

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

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

Conversational Vocal Intensity in Parkinson's Disease: Treatment and Environmental Comparisons. [2023]

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

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

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

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

6. England pubmed.ncbi.nlm.nih.gov

Staying UpRight in Parkinson's disease: A pilot study of a novel wearable postural intervention. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Vibrotactile Feedback Alters Dynamics Of Static Postural Control In Persons With Parkinson's Disease But Not Older Adults At High Fall Risk. [2018]