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

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT05881460

Run by

Synergic Medical Technologies, Inc.

People needed

30

Starts

2023-07-12

Expected to finish

2026-11-01

Last updated by the study team

2026-04-24

Who can join

Age: 45 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Severe depression or suicide ideation (as assessed with Beck Depression Inventory (BDI), BDI <28, and Columbia Suicide Severity Rating scale (SSRS), C-SSRS < 4)
• BDI score > 28, indicating severe depression that precludes ability to adhere to protocol. Any subject with such a score will be referred to a Primary Care Physician (PCP) or physician for further evaluation and management of depression. Individuals with a BDI score of 17-28 will be excluded if any of the following conditions are met: (1) individual is suicidal, (2) is in need of depression treatment modification currently or (3) depressive symptoms likely to interfere with adherence to study protocol. Any subject with such a score will be referred to a PCP or physician for further evaluation and management of depression.
• Presence of other neurological or musculoskeletal disorders as determined by the physician during screening.
• Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 2-month
• Physical limitations unrelated to Parkinson's disease
• Recent change or addition of psychoactive medications for non-parkinsonian treatments
• Any kind of brain surgery or neurostimulators
• Pregnancy, breastfeeding, or lack of reliable contraception in women of childbearing age

Where it is running

• Oregon Health & Science Institution — Portland, Oregon, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.