Vibrotactile Coordinated Reset: A Treatment for Early Stage Parkinson's Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Stanford University
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Vivek P. Buch
Protocol Director
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Ages 18 and older
- •Idiopathic Parkinson's disease Hoehn and Yahr stage I
- •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.
- •Feels comfortable going off PD related medication during in person study visits
- •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
- •Physical limitations unrelated to PD that would affect motor ratings
- •Brain surgery
- •Patient is unable to communicate properly with staff (i.e., severe speech problems)
- •Excessive drooling
- •A type of hair style that would impede the use of an EEG cap
- •Sensory abnormalities of the fingertips
Outcomes
Primary Outcomes
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication
Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months
This scale measures motor ability within Parkinson's patients. For part 3, the scales minimum values is 0 and max value is 132. Higher scores indicate more impaired motor ability, while lower scores indicate less impaired motor ability. A score of 0 indicates no motor impairment. Assessment will be performed while participants are off PD medication.
Secondary Outcomes
- Parkinsons disease quality of life questionnaire-39 (PDQ-39)(Baseline, 6 months, 12 months, 18 months, 24 months)
- Freezing of gait questionnaire (FOG)(Baseline, 6 months, 12 months, 18 months, 24 months)
- Smell threshold(Baseline, 6 months, 12 months, 18 months, 24 months)
- Visual acuity(Baseline, 6 months, 12 months, 18 months, 24 months)
- Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1(Baseline, 6 months, 12 months, 18 months, 24 months)
- Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2(Baseline, 6 months, 12 months, 18 months, 24 months)
- Visual contrast sensitivity(Baseline, 6 months, 12 months, 18 months, 24 months)
- Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4(Baseline, 6 months, 12 months, 18 months, 24 months)
- Smell Identification(Baseline, 6 months, 12 months, 18 months, 24 months)
- Smell discrimination(Baseline, 6 months, 12 months, 18 months, 24 months)
- Spontaneous EEG beta band power(Baseline, 6 months, 12 months, 18 months, 24 months)