Status:
TERMINATED
Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease
Lead Sponsor:
Synergic Medical Technologies, Inc.
Collaborating Sponsors:
Stanford University
Conditions:
Parkinson Disease
Eligibility:
All Genders
45-85 years
Phase:
NA
Brief Summary
The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within Parkinson's patients. vCR will be administered with a device called the...
Detailed Description
Current treatments for Parkinson's disease include medications, surgical measures, or a combination of both. However, long term use of medications can result intolerable side effects, especially at hi...
Eligibility Criteria
Inclusion
- Between the ages of 45-85
- Diagnosis of idiopathic Parkinson's disease
- Bilateral impairment, as defined as Hoehn \& Yahr Stages II-IV in the on-medication state
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III motor improvement greater than or equal to 30% when on medication compared to when off medication.
- Participants must be on stable dose of dopaminergic medication for 1 month prior to baseline visit.
- Able to provide informed consent.
- 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.
- Participants must speak English and can communicate with staff without the need of an interpreter.
- 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 recordings
- Exclusion Criteria
- Presence of other forms of non-idiopathic parkinsonism, including but not limited to atypical parkinsonism, medication-induced parkinsonism, and vascular parkinsonism.
- Presence of other brain diseases (i.e. major depression, dementia, Attention Deficit/Hyperactivity Disorder (ADHD) psychosis, etc…).
- Severe depression, severe anxiety, or severe psychosis for the purpose of excluding candidates at an elevated risk of suicidal tendencies.
- Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 30 days.
- Physical limitations unrelated to Parkinson's disease.
- Speech problems or excessive drooling so severe patient cannot communicate properly to staff.
- Presences of dopamine dysregulation syndrome.
- On dopamine agonist(s) and exhibits compulsive behaviors.
- Current delirium
- Pregnancy, breastfeeding, or trying to get pregnant during the duration of the study.
- History of epilepsy or traumatic brain injury.
- Brain surgery (i.e. DBS implantation) or craniotomy.
- Neurostimulator.
- A type of hairstyle that would impede the use of a EEG cap
- Severe sensory abnormalities of the fingertips such as vibratory urticaria.
- Current or ongoing hallucinations, delusions.
- The PI and study's neurologist deems the patient ineligible.
- Patient has a functional movement disorder that prevents accurate Parkinson's disease evaluations
Exclusion
Key Trial Info
Start Date :
December 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2022
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04877015
Start Date
December 7 2021
End Date
October 14 2022
Last Update
December 27 2022
Active Locations (1)
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1
Stanford University
Stanford, California, United States, 94305