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

Prior treatment

• Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 2-month
• Recent change or addition of psychoactive medications for non-parkinsonian treatments
• Any kind of brain surgery or neurostimulators

Other illness

• 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.
• Physical limitations unrelated to Parkinson's disease

Age

• Pregnancy, breastfeeding, or lack of reliable contraception in women of childbearing age

• 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.