35 Participants Needed

Non-Invasive Vibration Therapy for Parkinson's Disease

JY
KP
Overseen ByKristina Pfeifer
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

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.12345

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.12356

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.12578

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.

Eligibility Criteria

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.
See 3 more

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
See 7 more

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 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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Vibrotactile Coordinated Reset (vCR)Experimental Treatment1 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.

Find a Clinic Near You

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

References

Short-term effects of vibration therapy on motor impairments in Parkinson's disease. [2009]
Clinical Efficacy and Dosing of Vibrotactile Coordinated Reset Stimulation in Motor and Non-motor Symptoms of Parkinson's Disease: A Study Protocol. [2023]
Whole body vibration versus conventional physiotherapy to improve balance and gait in Parkinson's disease. [2022]
Effects of vibratory stimulation on balance and gait in Parkinson's disease: a systematic review and meta-analysis. [2021]
The effects of random whole-body-vibration on motor symptoms in Parkinson's disease. [2022]
Safety and Tolerability of a Wearable, Vibrotactile Stimulation Device for Parkinson's Disease. [2021]
Vibrotactile Coordinated Reset Stimulation for the Treatment of Neurological Diseases: Concepts and Device Specifications. [2020]
Vibrotactile Feedback Alters Dynamics Of Static Postural Control In Persons With Parkinson's Disease But Not Older Adults At High Fall Risk. [2018]
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