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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

Not Applicable

Study Type : Interventional
Estimated Enrollment : 10 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Vibrotactile Coordinated Reset for the Treatment of Post Surgery Refractory Parkinson's Disease Patients
Actual Study Start Date : August 20, 2024
Estimated Primary Completion Date : November 21, 2025
Estimated Study Completion Date : November 21, 2025
Arm Intervention/treatment

Experimental: Vibrotactile Coordinated Reset (vCR)

Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. A specific pattern of vibration to each fingertip is delivered which theoretically disrupts abnormal synchrony in the brain.

Device: Vibrotactile Coordinated Reset (vCR)
Ages Eligible for Study: 35 Years to 92 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Age at the time of enrollment: 35 - 92 years
  • Diagnosis of idiopathic Parkinson's disease
  • Surgical treatment for Parkinson's disease that does not involve Deep Brain Stimulation
  • Fluent in English
  • Appropriate social support if required during an off state.
  • 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.
  • Lives in the United States
Exclusion Criteria
  • Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies
  • Any current drug or alcohol abuse.
  • 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.
  • Pregnancy, breast-feeding or wanting to become pregnant
  • Patient is unable to communicate properly with staff (i.e., severe speech problems)
  • Excessive drooling
  • Sensory abnormalities of the fingertips
  • Deep Brain Stimulation treatment
  • 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

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

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Locations

Not yet recruiting

United States, California

Stanford University

Stanford, California, United States, 94305