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

35 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 advanced stage Parkinson's symptoms. VCR will be administered with a device called the Stanford CR 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.

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.

Is non-invasive vibration therapy safe for humans?

Research shows that non-invasive vibration therapy, including wearable vibrotactile devices, is generally safe and well tolerated in humans, with studies reporting no significant adverse effects. ^{1 2 3 4 5}

How does the treatment Vibrotactile Coordinated Reset differ from other treatments for Parkinson's disease?

Vibrotactile Coordinated Reset (vCR) is unique because it is a non-invasive therapy that uses gentle vibrations on the fingertips to disrupt abnormal brain rhythms, aiming to improve motor symptoms in Parkinson's disease. Unlike traditional treatments that often involve medication or invasive procedures, vCR focuses on desynchronizing neural networks to provide long-lasting relief from symptoms. ^{1 2 3 6 7}

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

Research shows that vibration therapy, including Vibrotactile Coordinated Reset, can improve motor symptoms like tremor and rigidity in Parkinson's patients. Studies have demonstrated that these therapies can lead to better motor control and functional outcomes, suggesting they may be a promising non-drug treatment option. ^{1 2 3 4 8}

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 between 35 and 92 years old.

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]

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]

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]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Short-term effects of vibration therapy on motor impairments in Parkinson's disease. [2009]

2. 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]

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

Whole body vibration versus conventional physiotherapy to improve balance and gait in Parkinson's disease. [2022]

4. Italy pubmed.ncbi.nlm.nih.gov

Effects of vibratory stimulation on balance and gait in Parkinson's disease: a systematic review and meta-analysis. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of random whole-body-vibration on motor symptoms in Parkinson's disease. [2022]

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

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

8. 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]