NCT04877015

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• 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 ability within Parkinson's patients. vCR will be administered with a device called the VT Brain Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. This study will include a dedicated sham that will aid in understanding true treatment effects from vCR.

Detailed description

Current treatments for Parkinson's disease include medications, surgical measures, or a combination of both. However, long term use of medications can result intolerable side effects, especially at higher doses. If patients under go Deep Brain Stimulation (DBS) surgery, risks include risk of stroke, infection, seizure, hemorrhage or others we may not anticipate. Our investigators hope to confirm a non-invasive method of applying the stimulation by vibrotactile stimulation delivered through the fingertips will alleviate severity in motor symptoms in Parkinson's patients

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Active Vibrotactile Coordinated Reset (vCR)	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 (vCR)	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: 2021-12-07
• Primary completion: 2022-10-14
• Completion: 2022-10-14
• First posted: 2021-05-07
• Last updated: 2022-12-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study