taVNS in Mild to Moderate Parkinson's Disease

Not Applicable

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion criteria:

Dementia or Montreal Cognitive Assessment score <24
Parkinson's Disease psychosis
Ear trauma
Facial pain
Traumatic Brain Injury or clinical history of stroke
Metal implants above the shoulders
History of myocardial infarction or arrhythmia, bradycardia
Active respiratory disorder
Alcohol or substance use disorders
History of Deep Brain Stimulation (DBS) or other brain surgery
Epilepsy
Pregnancy
B-Blockers, dopamine blocking agent, antiarrhythmic medication, acetylcholine esterase inhibitor, midodrine, florinef, droxidopa, or anticholinergic drugs

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Sham Stimulation	Sham Stimulation	-
Active taVNS	Active taVNS	-

Primary Outcome Measures

Name	Time	Method
Change in Motor Function Score as Assessed by Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	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 Outcome Measures

Name	Time	Method
Change in Cognitive Function Score	Screening to Day 13 (Visit 9)	Digit span forward is an investigator administered test looking at attention. The possible range for Digit Span Forward is 0-16, same for Digit Span Backward. Higher scores reflect better focused attention and working memory. An increase in score from pre-post would indicate improvement.