Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Synergic Medical Technologies, Inc.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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 VT Brain 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. This study will include a dedicated sham that will aid in understanding true treatment effects from vCR.
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 higher doses. If patients under go Deep Brain Stimulation (DBS) surgery, risks include risk of stroke, infection, seizure, hemorrhage or others we may not anticipate. Our investigators hope to confirm a non-invasive method of applying the stimulation by vibrotactile stimulation delivered through the fingertips will alleviate severity in motor symptoms in Parkinson's patients
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3
Time Frame: 14months
This scale measures motor ability within Parkinson's patients. For part 3, the scales minimum values is 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. This evaluation will be done in person at baseline, 3,6 and 7 months. The remote version will be done at 10, 13 and 14 months
Secondary Outcomes
- Spontaneous electroencephalography (EEG)(7 months)
- Parkinson's disease sleep scale (PDSS)(14 months)
- Vibration-only evoked EEG potentials(7 months)
- PD Quality of Life Questionnaire-39 (PDQ-39)(14 months)
- University of Pennsylvania Smell Identification Test (UPSIT)(7 months)
- Levodopa equivalent daily dose (LEDD)(14 months)
- Sensorimotor task EEG(7 months)
- Vibratory temporal discrimination task (VTDT)(7 months)
- Speech and voice assessments(7 months)
- Kinesia One motor evaluation(14 months)
- Freezing of Gait Questionnaire(14 months)