Status:
NOT_YET_RECRUITING
Vibrotactile Coordinated Reset (vCR) for the Treatment of Advanced Parkinson's Disease Patients Who Have Previously Received vCR Stimulation
Lead Sponsor:
Stanford University
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
The purpose of this study is to test the efficacy of vibrotactile coordinated reset(vCR) stimulation on human subject participants with advanced stage Parkinson's Disease who have previously received ...
Eligibility Criteria
Inclusion
- Any adult age 18 and 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 Electroencephalography (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 Parkinson's Disease(PD) related medication during in person study visits
- Lives in the United States
- Having previously been enrolled in a vCR pilot study
Exclusion
- 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
- Craniotomy
- Brain surgery
- Patient is unable to communicate properly with staff (i.e., severe speech problems)
- Excessive drooling
- A type of hairstyle that would impede the use of an EEG cap
- Sensory abnormalities of the fingertips
- Patient is taking a medication that may cause significant withdrawal effects.
- Presence or diagnosis of Essential Tremor, psychogenetic tremor, functional tremor and any other non- pathological or non-Parkinsonian tremors
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06559098
Start Date
January 1 2025
End Date
September 1 2027
Last Update
September 5 2024
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