Non-invasive treatment for Parkinson's disease using vibrotactile stimulation
Vibrotactile Coordinated Reset: a Non-invasive Treatment for Parkinson's Disease
This study is testing if a new device that uses gentle vibrations on the fingertips can help people with Parkinson's disease move better and possibly reduce their need for medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | Synergic Medical Technologies, Inc. Industry-sponsored |
| Locations | 1 site (Portland, Oregon) |
| Trial ID | NCT05881460 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of Vibrotactile Coordinated Reset (vCR) stimulation on motor function in individuals with Parkinson's disease. Participants will use a device called the Vibrotactile (VT) Touch, which delivers non-invasive stimulation to the fingertips. The study employs a crossover design, allowing participants to serve as their own control by receiving both active and sham stimulation. The goal is to assess whether vCR can improve motor abilities and potentially reduce the need for increased dopamine medication.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 45-85 with a diagnosis of idiopathic Parkinson's disease and moderate-stage impairment.
Not a fit: Patients with advanced Parkinson's disease or those who are not responsive to levodopa may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-invasive alternative to current Parkinson's disease therapies, potentially improving motor function and reducing medication side effects.
How similar studies have performed: While similar non-invasive approaches have been explored, this specific method of vibrotactile stimulation is novel and has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Between the ages of 45-85 2. 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 3. Bilateral, moderate-stage impairment, as defined as Hoehn \& Yahr Stages II-IV in the on-medication state 4. Able to walk and stand unassisted 5. Participants must be on a stable regimen of PD medication (at least 4 weeks prior to enrollment) 6. Responsive to levodopa (self-reported) 7. Willing to keep exercise and medication regimen as stable as possible for the duration of the study 8. Able to provide informed consent 9. Independently, or with social support, able to use technology and access virtual meeting if needed to troubleshoot technology 10. Participants must speak English and can communicate with staff 11. 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. Exclusion Criteria: 1. 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. 2. Presence of other neurological or musculoskeletal disorders as determined by the physician during screening. 3. Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 2-month 4. Physical limitations unrelated to Parkinson's disease 5. Recent change or addition of psychoactive medications for non-parkinsonian treatments 6. Any kind of brain surgery or neurostimulators 7. Pregnancy, breastfeeding, or lack of reliable contraception in women of childbearing age
Where this trial is running
Portland, Oregon
- Oregon Health & Science Institution — Portland, Oregon, United States (Recruiting)
Study contacts
- Principal investigator: Jeff Kraakivk, MD — Oregon Health and Science University
- Study coordinator: Jeff Kraakevik, MD
- Email: kraakevi@ohsu.edu
- Phone: 503-494-8311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.