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NCT05545826 | NOT YET RECRUITING | Parkinson Disease

Vibrotactile Coordinated Reset (VCR): A Treatment for Early Stage Parkinson's Disease
Sponsor:

Stanford University

Information provided by (Responsible Party):

Vivek P. Buch

Brief Summary:

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on early stage Parkinson's symptoms. 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

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Vibrotactile Coordinated Reset: A Treatment for Early Stage Parkinson's Disease
Actual Study Start Date : 2025-04-01
Estimated Primary Completion Date : 2027-10-20
Estimated Study Completion Date : 2027-10-20

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Ages 18 and older
  • 2. Idiopathic Parkinson's disease Hoehn and Yahr stage I
  • 3. Fluent in English
  • 4. Appropriate social support if required during an off state.
  • 5. 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.
  • 6. Feels comfortable going off PD related medication during in person study visits
  • 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. Physical limitations unrelated to PD that would affect motor ratings
  • 6. Craniotomy
  • 7. Brain surgery
  • 8. Patient is unable to communicate properly with staff (i.e., severe speech problems)
  • 9. Excessive drooling
  • 10. A type of hair style that would impede the use of an EEG cap
  • 11. Sensory abnormalities of the fingertips
  • 12. Nasal dysfunction unrelated to smell loss
Vibrotactile Coordinated Reset (VCR): A Treatment for Early Stage Parkinson's Disease

Location Details

NCT05545826

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How to Participate

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Locations

Not yet recruiting

United States, California

Stanford University

Stanford, California, United States, 94305