Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease 2
Parkinson Disease
About this trial
This is an interventional treatment trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Sites / Locations
- Oregon Health & Science InstitutionRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Active vibrotactile coordinated reset
Sham vibrotactile coordinated reset
Participants will receive active Vibrotactile Coordinated Reset stimulation.
Participants will receive inactive Vibrotactile Coordinated Reset stimulation.