What is the mechanism of action of this treatment?

Common treatments for Parkinson's Disease (PD) include dopaminergic medications, deep brain stimulation (DBS), and non-invasive neuromodulation techniques like Vibrotactile Coordinated Reset (vCR). Dopaminergic medications, such as carbidopa-levodopa, work by replenishing dopamine levels in the brain, which are deficient in PD patients. DBS involves surgically implanting electrodes to modulate neural activity in specific brain regions, thereby reducing motor symptoms. Non-invasive techniques like vCR use sensory feedback to disrupt abnormal neural patterns and improve motor function. These treatments are essential for managing PD symptoms, enhancing motor control, and improving patients' quality of life.

What side effects are associated with this type of intervention?

Common treatments for Parkinson's Disease include dopaminergic therapies like levodopa, dopamine agonists, and MAO B inhibitors, which can cause side effects such as nausea, dizziness, hallucinations, and dyskinesia. Non-invasive neuromodulation therapies, similar to Vibrotactile Coordinated Reset (vCR) stimulation, have shown promise in improving motor function. Side effects of these neuromodulation therapies can include skin irritation, discomfort at the stimulation site, and transient changes in sensation. Overall, these treatments aim to manage symptoms with varying degrees of side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Parkinson's Disease, primarily focusing on pharmacological interventions such as levodopa-carbidopa, dopamine agonists, and MAO-B inhibitors. For non-pharmacological treatments, deep brain stimulation (DBS) is a well-established surgical option. While specific FDA approvals for non-invasive neuromodulation techniques like Vibrotactile Coordinated Reset (vCR) stimulation are not detailed, similar approaches such as transcranial magnetic stimulation (TMS) have shown promise in clinical trials. These techniques aim to modulate neural activity to improve motor function and manage symptoms in Parkinson's Disease patients.

What other types of research exist?

Promising novel alternatives to Vibrotactile Coordinated Reset (vCR) stimulation for Parkinson's Disease patients include: 1) Deep Brain Stimulation (DBS) of the subthalamic nucleus or globus pallidus internus, which has shown long-term efficacy in managing motor symptoms. 2) Transcranial Direct Current Stimulation (tDCS), which has been studied for its potential to enhance motor function and neuroplasticity. 3) Non-invasive neuromodulation techniques such as transcranial magnetic stimulation (TMS) and focused ultrasound, which are being explored for their therapeutic benefits in PD. 4) Pharmacological advancements, including new formulations of levodopa and dopamine agonists, as well as novel drug classes targeting non-dopaminergic pathways.

← Back to Search

Behavioural Intervention

Vibrotactile Stimulation for Parkinson's Disease

N/A

Recruiting

Led By Jeff Kraakivk, MD

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, 3 months, 5 months

Summary

This trial tests a new treatment that uses gentle fingertip vibrations to help people with Parkinson's disease move better. It targets those who have severe side effects from current treatments or find them invasive. The vibrations aim to reset abnormal brain activity to improve movement. Recent studies have suggested that vibration therapy may have a positive influence on motor symptoms in individuals with Parkinson's disease.

Who is the study for?

This trial is for people aged 45-85 with moderate-stage Parkinson's disease who respond to levodopa, are on stable PD meds, and can walk unassisted. They must be able to use technology, live near the clinic, and not be in other trials or have conditions that could interfere.

What is being tested?

The study tests a non-invasive device called Vibrotactile (VT) Touch which delivers vibrotactile coordinated reset stimulation (vCR). It aims to improve motor function in Parkinson's patients and may delay the need for increased dopamine medication.

What are the potential side effects?

Since vCR uses a non-invasive device without drugs, side effects might be minimal but could include discomfort at the site of stimulation or skin irritation from the device.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 months, 3 months, 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 months, 3 months, 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 months, 3 months, 5 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

Change in Movement Disorders Society's Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part 3

Secondary study objectives

Change in freezing severity index

Change in gait speed as measured by Ambulatory Parkinson's Disease Monitoring (APDM) Mobility Lab

Quality of life improvements

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active vibrotactile coordinated resetActive Control1 Intervention

Participants will receive active Vibrotactile Coordinated Reset stimulation.

Group II: Sham vibrotactile coordinated resetPlacebo Group1 Intervention

Participants will receive inactive Vibrotactile Coordinated Reset stimulation.

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

Common treatments for Parkinson's Disease (PD) include dopaminergic medications, deep brain stimulation (DBS), and non-invasive neuromodulation techniques like Vibrotactile Coordinated Reset (vCR). Dopaminergic medications, such as carbidopa-levodopa, work by replenishing dopamine levels in the brain, which are deficient in PD patients. DBS involves surgically implanting electrodes to modulate neural activity in specific brain regions, thereby reducing motor symptoms. Non-invasive techniques like vCR use sensory feedback to disrupt abnormal neural patterns and improve motor function. These treatments are essential for managing PD symptoms, enhancing motor control, and improving patients' quality of life.

Botulinum Toxin in Movement Disorders: An Update.Tapping the Potential of Multimodal Non-invasive Brain Stimulation to Elucidate the Pathophysiology of Movement Disorders.Effect of Combined Therapy of Virtual Reality and Transcranial Direct Current Stimulation in Children and Adolescents With Cerebral Palsy: A Study Protocol for a Triple-Blinded Randomized Controlled Crossover Trial.