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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Maximum Age: 85
Healthy Volunteers: f
View:

• Between the ages of 45-85

• Diagnosis of idiopathic Parkinson's disease from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia and one or more of the following: rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar, or proprioceptive conditions

• Bilateral, moderate-stage impairment, as defined as Hoehn \& Yahr Stages II-IV in the on-medication state

• Able to walk and stand unassisted

• Participants must be on a stable regimen of PD medication (at least 4 weeks prior to enrollment)

• Responsive to levodopa (self-reported)

• Willing to keep exercise and medication regimen as stable as possible for the duration of the study

• Able to provide informed consent

• Independently, or with social support, able to use technology and access virtual meeting if needed to troubleshoot technology

⁃ Participants must speak English and can communicate with staff

⁃ Patients live close to or in the area of where the clinic is located and are able to travel to the clinic for all screening and assessment appointments.

Locations
United States
Oregon
Oregon Health & Science Institution
RECRUITING
Portland
Contact Information
Primary
Jeff Kraakevik, MD
kraakevi@ohsu.edu
503-494-8311
Time Frame
Start Date: 2023-07-12
Estimated Completion Date: 2026-01
Participants
Target number of participants: 30
Treatments
Active_comparator: Active vibrotactile coordinated reset
Participants will receive active Vibrotactile Coordinated Reset stimulation.
Sham_comparator: Sham vibrotactile coordinated reset
Participants will receive inactive Vibrotactile Coordinated Reset stimulation.
Sponsors
Leads: Synergic Medical Technologies, Inc.

This content was sourced from clinicaltrials.gov