What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include pharmacological therapies, deep brain stimulation (DBS), and non-invasive methods like vibrotactile stimulation. Pharmacological treatments, such as levodopa and dopamine agonists, can cause side effects like nausea, dizziness, hallucinations, and dyskinesia. DBS, while effective, carries risks of infection, hemorrhage, and hardware malfunctions, though severe adverse effects are rare. Non-invasive treatments like CR Vibrotactile Stimulation are still under study, but generally aim to minimize side effects by avoiding surgical risks and focusing on external modulation of symptoms.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, primarily focusing on pharmacological and invasive methods. Pharmacological treatments include levodopa combined with carbidopa, which remains the gold standard for managing motor symptoms. Other medications like dopamine agonists, MAO-B inhibitors, and COMT inhibitors (e.g., tolcapone) are also approved. For more advanced stages, invasive treatments like Deep Brain Stimulation (DBS) are used. While non-invasive neuromodulation techniques like Transcranial Magnetic Stimulation (TMS) have shown promise, they are generally considered second-line treatments. Specific FDA approvals for non-invasive methods similar to CR Vibrotactile Stimulation are not detailed, but the general trend is towards exploring neuromodulation as an adjunctive therapy.

What other types of research exist?

Promising, novel alternatives to Coordinated Reset (CR) Vibrotactile Stimulation for Parkinson's Disease patients include: 1) Transcranial Magnetic Stimulation (TMS), which has shown efficacy in improving motor function by modulating brain activity. 2) Noninvasive Vagus Nerve Stimulation (nVNS), which may help in reducing motor symptoms through neuromodulation. 3) Peripheral Nerve Stimulation, particularly at the wrist, which can modulate both peripheral and central components of the tremor network. These alternatives offer non-invasive options that target the underlying pathophysiological mechanisms of PD.

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Behavioural Intervention

Vibrotactile Stimulation for Parkinson's Disease

N/A

Recruiting

Led By Phan Luu, PhD

Research Sponsored by Synergic Medical Technologies, Inc.

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 baseline, 2 months, 4 months

Summary

This trial tests a vibration-based treatment to help people with moderate Parkinson's disease improve their movement. The vibrations aim to reset abnormal brain activity causing the symptoms. Participants will use the device regularly at home. Earlier studies show that whole-body vibration (WBV) has beneficial effects on neuromuscular performance in older adults and may be a viable treatment option for people with Parkinson disease (PD).

Who is the study for?

This trial is for individuals aged 45-90 with moderate stage idiopathic Parkinson's Disease (PD), who can undergo EEG procedures. It's not open to patients on dopamine agonist medications if they show compulsive behaviors.

What is being tested?

The study tests a non-invasive vibrotactile stimulation called coordinated reset (CR) against a sham procedure, aiming to improve motor symptoms in PD by disrupting the disease's pathophysiological mechanisms.

What are the potential side effects?

As this is a non-invasive treatment involving sensory stimulation, side effects are expected to be minimal but may include discomfort or skin irritation at the site of vibration.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 months, 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 months, 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 months, 4 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 Disorder Society - Change in Universal Parkinson Disease Rating Scale (MDS-UPDRS)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active vibrotactile coordinated resetActive Control1 Intervention

mechanical vibrotactile stimulation to the fingers in a defined pattern

Group II: Sham vibrotactile coordinated resetPlacebo Group1 Intervention

mechanical vibrotactile stimulation to the fingers in a defined pattern

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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) primarily aim to manage symptoms by addressing the dopamine deficiency in the brain. Levodopa, often combined with carbidopa, is the most effective treatment, as it converts to dopamine in the brain, replenishing the depleted neurotransmitter. Dopamine agonists mimic dopamine's effects by stimulating dopamine receptors, while MAO-B inhibitors prevent the breakdown of dopamine, prolonging its action. These treatments are crucial as they help alleviate motor symptoms such as rigidity, bradykinesia, and tremor, improving patients' quality of life. Similar to these pharmacological approaches, the Coordinated Reset (CR) Vibrotactile Stimulation aims to restore motor function by disrupting abnormal neural patterns, offering a non-invasive alternative that targets the underlying pathophysiological mechanisms of PD.