About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Vibrotactile Coordinated Reset
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
MDS-UPDRS Part 3
The Movement Disorder Society Unified Parkinsons Disease Rating Scale Part 3 assessment, obtained while the participant is off medication, is a scale that measures motor ability within Parkinsons patients. For part 3, the scales minimum values are 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.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: