Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Stanford University
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication
- Status
- Enrolling by Invitation
- Last Updated
- last year
Overview
Brief Summary
The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on advanced stage Parkinson's symptoms. VCR will be administered with a device called the Stanford CR 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.
Detailed Description
This study involves gentle vibrations delivered to the finger-tips which have been shown in pilot studies to be effective in reducing motor symptoms associated with Parkinson's Disease.
Investigators
Vivek P. Buch
Protocol Director
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Age at the time of enrollment: 18 years of age or older
- •Idiopathic Parkinson's Symptoms between hoehn and yahr stages 2 to 4
- •Fluent in English
- •If patient is on medication that affects brain function or alters EEG activity, the patient must feel comfortable going off this medication prior to EEG recording
- •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. This assessment is performed while participants are off Parkinson's-related medication.
Secondary Outcomes
- Levodopa equivalent daily dose (LEDD)(Baseline, 24 months)
- Communicative Participation Item Bank (CPIB; Short Form)(Baseline, 6 months, 12 months, 18 months, 24 months)
- 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)
- 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 4(Baseline, 6 months, 12 months, 18 months, 24 months)
- Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) on medication(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)
- Voice Handicap Index (VHI-10)(Baseline, 6 months, 12 months, 18 months, 24 months)
- Parkinson's disease cognitive functional rating scale (PD-CFRS)(Baseline, 6 months, 12 months, 18 months, 24 months)
- Spontaneous EEG beta band power(Baseline, 6 months, 12 months, 18 months, 24 months)
- Vibratory threshold(Baseline, 6 months, 12 months, 18 months, 24 months)