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NCT05558189 | NOT YET RECRUITING | Parkinson Disease

Vibrotactile Coordinated Reset for the Treatment of Post Surgery Refractory Parkinson's Disease Patients
Sponsor:

Stanford University

Information provided by (Responsible Party):

Peter Tass, MD, PhD

Brief Summary:

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on refractory post-surgery PD. vCR will be administered with a device called the Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. Patients will be followed for two years.

Condition or disease

Parkinson Disease

Intervention/treatment

Vibrotactile Coordinated Reset (vCR)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Vibrotactile Coordinated Reset for the Treatment of Post Surgery Refractory Parkinson's Disease Patients
Actual Study Start Date : 2025-08-20
Estimated Primary Completion Date : 2026-11-21
Estimated Study Completion Date : 2026-11-21

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 35 Years to 92 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Age at the time of enrollment: 35 - 92 years
  • 2. Diagnosis of idiopathic Parkinson's disease
  • 3. Surgical treatment for Parkinson's disease that does not involve Deep Brain Stimulation
  • 4. Fluent in English
  • 5. Appropriate social support if required during an off state.
  • 6. Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes.
  • 7. Lives in the United States
Exclusion Criteria
  • 1. Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies
  • 2. Any current drug or alcohol abuse.
  • 3. Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
  • 4. Pregnancy, breast-feeding or wanting to become pregnant
  • 5. Patient is unable to communicate properly with staff (i.e., severe speech problems)
  • 6. Excessive drooling
  • 7. Sensory abnormalities of the fingertips
  • 8. Deep Brain Stimulation treatment
  • 9. PD symptoms so severe and that the patient is bed-bound
Vibrotactile Coordinated Reset for the Treatment of Post Surgery Refractory Parkinson's Disease Patients

Location Details

NCT05558189

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Stanford University

Stanford, California, United States, 94305