Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Mild to Moderate Parkinson's Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Medical University of South Carolina
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- Change in Motor Function Score as Assessed by Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to find out whether a non-invasive form of nerve stimulation called transcutaneous vagus nerve stimulation (taVNS) is safe and effective in people with Parkinson's Disease.
Investigators
Vanessa Hinson
Program Director
Medical University of South Carolina
Eligibility Criteria
Inclusion Criteria
- •Age: 40-79 y
- •Idiopathic Parkinson's Disease Diagnosis
- •Disease Stage: Hoehn and Yahr stage 2-3
- •Patient requires a minimum of 3 doses of levodopa daily
- •Willingness to be videotaped
- •Exclusion criteria:
- •Dementia or Montreal Cognitive Assessment score \<24
- •Parkinson's Disease psychosis
- •Ear trauma
- •Facial pain
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Motor Function Score as Assessed by Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III
Time Frame: Baseline (Visit 1) to Day 14 (Visit 10)
The MDS-UPDRS is a rating scale used in research and clinic to rate the severity of Parkinson's Disease. A low score indicates mild disease and a high score more advanced disease. The possible range for MDS-UPDRS Part III is 0-132. Higher scores reflect greater motor disturbance. A decline in score from pre-post would indicate improvement. This outcome observed Part III of UPDRS motor examination. Information on cover page: The MDS-UPDRS has four parts: Part I (non-motor experiences of daily living), Part II (motor experiences of daily living), Part III (motor examination) and Part IV (motor complications). Part I has two components: IA concerns a number of behaviors that are assessed by the investigator with all pertinent information from patients and caregivers, and IB is completed by the patient with or without the aid of the caregiver, but independently of the investigator. These sections can, however, be reviewed by the rater to ensure that all questions are answered clea
Secondary Outcomes
- Change in Cognitive Function Score(Screening to Day 13 (Visit 9))