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VCR: A Treatment for Early Stage Parkinson's Disease
Trial ID: NCT05545826
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 vibrotactile axon 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.
Vibrotactile Coordinated Reset: A Treatment for Early Stage Parkinson's Disease
1. Age at the time of enrollment: 35 - 90 years
2. Idiopathic Parkinson's Symptoms between hoehn and yahr stage 1
3. Fluent in English
4. 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
5. Appropriate social support if required during an off state.
6. 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.
7. Feels comfortable going off PD related medication during in person study visits
8. Lives in the United States
1. Any significant neuro-psychiatric problems, including acute confusional state, ongoing
psychosis, or suicidal tendencies
2. Any current drug or alcohol abuse.
3. 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
4. Pregnancy, breast-feeding or wanting to become pregnant
5. Physical limitations unrelated to PD that would affect motor ratings
6. Craniotomy with the exception of burr holes.
7. Brain surgery
8. Patient is unable to communicate properly with staff (i.e., severe speech problems)
9. Excessive drooling
10. A type of hairstyle that would impede the use of an EEG cap
11. Sensory abnormalities of the fingertips
12. Nasal Disfunction unrelated to smell loss -
device: Vibrotactile coordinated reset
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