Vibrotactile Coordinated Reset for Parkinsons Patients Who Are on Dopaminergic Medication
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vibrotactile Coordinated Reset.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Idiopathic. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this clinical trial is to test the efficacy of vibrotactile coordinated reset stimulation to improve movement ability and other symptoms of human subject participants with Parkinsons Disease who take dopaminergic medication and are unable to withhold this medication. Participants will be followed for five years and make a total of five study visits.
Interventions
- Device Vibrotactile Coordinated Reset
The Stanford CR glove is designed to administer vibrotactile coordinated reset stimulation, which consists of vibratory stimulation of the fingertips delivered in a specific pattern which is design to disrupt and normalize abnormal brain synchrony.
Primary outcome measures
- MDS-UPDRS Part 3 [Time frame: Baseline, 6 months, 12 months, 18 months, 24 months]
Eligibility criteria
Inclusion criteria
- Age at the time of enrollment: Adults 18 and older
- Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4
- Fluent in English
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06583005 · 75389