What is the mechanism of action of this treatment?

Common treatments for Parkinson's Disease (PD) include medications like levodopa, which replenishes dopamine levels in the brain, and deep brain stimulation (DBS), which modulates neural activity through electrical impulses. These treatments aim to alleviate motor symptoms by addressing the dopamine deficiency and abnormal neural activity characteristic of PD. Non-invasive neuromodulation techniques, such as Vibrotactile Coordinated Reset (vCR), use patterned vibratory stimuli to reset abnormal neural oscillations without surgery. This approach is significant for PD patients as it offers a potentially safer and more accessible alternative to invasive treatments, aiming to improve motor function and quality of life.

What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease that involve non-invasive neuromodulation, such as transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS), generally have mild side effects. For TMS, side effects can include headaches, scalp discomfort, and a slight risk of inducing seizures, particularly in patients with epilepsy. nVNS may cause mild adverse events such as a warm sensation, numbness, redness, itching, tingling, muscle spasms, and localized pain. These treatments are generally well-tolerated and do not have serious adverse events.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, including medications like levodopa and deep brain stimulation (DBS) for more advanced cases. Non-invasive neuromodulation therapies, such as transcranial magnetic stimulation (TMS), have shown efficacy in clinical trials but are generally considered second-line treatments. While TMS is approved for other conditions, its use in Parkinson's Disease is still under investigation. The Vibrotactile Coordinated Reset (vCR) being studied is a novel approach that uses patterned vibratory stimuli, offering a non-invasive alternative to these existing treatments.

What other types of research exist?

Promising, novel alternatives to Vibrotactile Coordinated Reset (vCR) stimulation for Parkinson's Disease patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in reducing depressive symptoms in bipolar disorder and may have potential applications in Parkinson's Disease. 2) Transcranial Direct-Current Stimulation (tDCS), which has been explored for its cognitive enhancement effects in bipolar patients and could be beneficial for Parkinson's Disease. 3) Vagus Nerve Stimulation (VNS), which has demonstrated long-term benefits in treatment-resistant depression and may offer therapeutic potential for Parkinson's Disease.

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Vibrotactile Stimulation for Parkinson's Disease

N/A

Waitlist Available

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Feels comfortable going off PD related medication during in person study visits

Idiopathic Parkinson's Symptoms between hoehn and yahr stage 1

Must not have

Brain surgery

Patient is unable to communicate properly with staff (i.e., severe speech problems)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 6 months, 12 months, 18 months, 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called Vibrotactile Coordinated Reset stimulation (vCR) for people with early stage Parkinson's disease. The treatment uses a device called the Stanford Glove to send vibrations to the nervous system. It aims to provide a non-invasive alternative to common treatments like medication or surgery by helping the brain's nerve cells work better.

Who is the study for?

This trial is for English-speaking adults aged 35-90 in the U.S. with early stage Parkinson's (Hoehn and Yahr stage 1). Participants must be comfortable stopping their Parkinson's medication during visits, able to use technology for virtual meetings, and have social support if needed.

What is being tested?

The study tests Vibrotactile Coordinated Reset (vCR) using a device called vibrotactile axon Glove on early-stage Parkinson's symptoms. It offers a non-invasive treatment alternative, monitoring patients over two years.

What are the potential side effects?

Since vCR is non-invasive and doesn't involve drugs or surgery, side effects are minimal but may include discomfort at the glove contact points or skin irritation from prolonged use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am okay with stopping my Parkinson's disease medication for study visits.

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My Parkinson's is in the early stage (stage 1).

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I am between 35 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had brain surgery.

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I have severe difficulty speaking or communicating.

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I experience excessive drooling.

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I feel unusual sensations in my fingertips.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 6 months, 12 months, 18 months, 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 6 months, 12 months, 18 months, 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months, 12 months, 18 months, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication

Secondary study objectives

Freezing of gait questionnaire (FOG)

Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1

Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Parkinson's Disease (PD) include medications like levodopa, which replenishes dopamine levels in the brain, and deep brain stimulation (DBS), which modulates neural activity through electrical impulses. These treatments aim to alleviate motor symptoms by addressing the dopamine deficiency and abnormal neural activity characteristic of PD. Non-invasive neuromodulation techniques, such as Vibrotactile Coordinated Reset (vCR), use patterned vibratory stimuli to reset abnormal neural oscillations without surgery. This approach is significant for PD patients as it offers a potentially safer and more accessible alternative to invasive treatments, aiming to improve motor function and quality of life.

Essential tremor amplitude modulation by median nerve stimulation.Coordinated reset neuromodulation for Parkinson's disease: proof-of-concept study.