NCT05881460

Vibrotactile Coordinated Reset: a Non-invasive Treatment for Parkinson's Disease 2

Vibrotactile Coordinated Reset: a Non-invasive Treatment for Parkinson's Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Synergic Medical Technologies, Inc. · Industry
• Sex: All
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor function in people with Parkinson's disease (PD). vCR will be administered with a device called the Vibrotactile (VT) Touch device. vCR can be used in conjunction with medication and is expected to delay the need to increase dopamine medication. It also provides a more flexible alternative to deep brain stimulation (DBS) in that the vCR therapy can be easily stopped or modified to better suit the patients' needs.

Detailed description

This vCR study will include a crossover design, where participants are their own control and receive both active stimulation and sham, aiding in understanding true treatment effects from vCR. Current treatments for PD include medications, surgical measures, or a combination of both. However, long term use of medications can result in intolerable side effects, especially at higher doses. Although DBS is FDA approved and an established method to manage symptoms of PD, it is an invasive and expensive procedure and may not improve all symptoms of PD. The team at Synergic Medical Technologies, Inc. developed a non-invasive method of applying vibrotactile stimulation delivered through the fingertips that has the potential of theoretically disrupting abnormal synchrony in the brain and thus alleviate severity in motor symptoms in people with PD. The purpose of this study is to test the use of vibrotactile stimulation on 30 participants with PD and vCRs effects on motor ability using the VT Touch.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Active vibrotactile coordinated reset	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.
DEVICE	Sham vibrotactile coordinated reset	Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. An inactive pattern of vibration to each fingertip is delivered which theoretically will not have the effects of active vCR.

Timeline

• Start date: 2023-07-12
• Primary completion: 2025-12-01
• Completion: 2026-01-01
• First posted: 2023-05-31
• Last updated: 2024-11-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study