What side effects are associated with this type of intervention?

Non-invasive neuromodulation treatments for Parkinson's Disease, such as transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS), generally have mild side effects. TMS can cause mild discomfort at the stimulation site, headaches, and in rare cases, seizures, particularly in patients with epilepsy. nVNS may cause mild device-associated adverse events like a warm sensation, numbness, redness, itching, tingling, muscle spasm, and pain in the arm, shoulder, or neck. Serious adverse events are uncommon with these treatments.

What prior FDA approvals exist?

Non-invasive neuromodulation treatments for Parkinson's Disease include transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS). TMS has shown efficacy in sham-controlled trials and is available in the United States and the United Kingdom. It is considered a second-line intervention for patients who do not respond to first-line therapies like triptans. nVNS has also shown potential benefits in the acute treatment of episodic migraine, which may be relevant for Parkinson's Disease management. These treatments offer alternatives to more invasive procedures like deep brain stimulation (DBS), which is typically reserved for severe cases.

What other types of research exist?

Promising non-invasive neuromodulation alternatives to Vibrotactile Coordinated Reset stimulation (vCR) for Parkinson's Disease patients include transcranial magnetic stimulation (TMS), which has shown efficacy in various studies for treatment-resistant conditions, and transcranial direct-current stimulation (tDCS), which has been systematically reviewed and meta-analyzed for its potential benefits. Cranial electrotherapy stimulation (CES) is another option, with pilot studies indicating safety and efficacy in related conditions.

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Behavioural Intervention

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called Vibrotactile Coordinated Reset stimulation (vCR) using a device known as the Stanford Glove. It targets Parkinson's Disease patients who have had surgery but still struggle with symptoms. The treatment uses vibrations to help reset brain activity and improve symptoms without the need for invasive procedures.

Who is the study for?

This trial is for Parkinson's Disease patients aged 35-90 in the U.S. who've had surgery (not DBS) for their condition, are comfortable with technology, and have support during off states. Excluded are those with severe psychiatric issues, substance abuse, recent or concurrent trial participation, pregnancy intentions, communication difficulties due to speech problems, excessive drooling or fingertip sensory abnormalities.

What is being tested?

The study tests a non-invasive treatment called Vibrotactile Coordinated Reset (vCR), delivered through a device named vibrotactile axon Glove. It aims to offer an alternative to levodopa or deep brain stimulation for post-surgery PD patients. Participants will be monitored over two years to assess vCR's effectiveness.

What are the potential side effects?

Since this is a non-drug intervention using tactile stimulation via a glove device, side effects may be minimal but could include skin irritation at contact points or temporary discomfort from the vibration stimulus.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) change from baseline to 24 months.

Secondary study objectives

Communicative Participation Item Bank (CPIB; Short Form) change from baseline to 24 months.

Gait

Levodopa equivalent daily dose (LEDD) change from baseline to 24 months

+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.

Do I qualify?Apply below to find out

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

Parkinson's Disease treatments primarily aim to manage symptoms by addressing the underlying dopaminergic deficit. Levodopa, the most common treatment, is converted to dopamine in the brain, replenishing the diminished neurotransmitter. Deep Brain Stimulation (DBS) involves implanting electrodes in specific brain regions to modulate abnormal neural activity. Non-invasive neuromodulation, such as Vibrotactile Coordinated Reset (vCR) stimulation, uses external devices to deliver patterned stimuli that can reset abnormal neural firing patterns. These treatments are crucial as they help alleviate motor symptoms, improve quality of life, and offer alternatives for patients who may not respond well to medication alone.

Botulinum Toxin in Movement Disorders: An Update.Deep Brain Stimulation for Treatment of Tremor.Coordinated reset neuromodulation for Parkinson's disease: proof-of-concept study.