taVNS in Mild to Moderate Parkinson's Disease (taVNS)

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Mild to Moderate Parkinson's Disease

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Active taVNS; Device: Sham Stimulation

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Stimulation	Device: Sham Stimulation; Sham stimulation involves identical perceptual threshold finding and stimulation parameters as active stimulation, with the exception of stimulation target. Sham stimulation will be delivered to the left earlobe, a target believed to have little to no vagal nerve innervation.
Active Comparator: Active taVNS	Device: Active taVNS; Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Motor Function Score as Assessed by Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	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	Baseline (Visit 1) to Day 14 (Visit 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cognitive Function Score	Delis-Kaplan Executive Function System (DKEFS) letter fluency is an investigator administered test that assesses verbal fluency. Higher scores indicate more correct responses. A positive value of change means an improvement in fluency. A decrease in score represents decrease in fluency. The minimum score is 0 and there is no maximum score. The raw score is total from letters F, A, and S.	Screening to Day 13 (Visit 9)
Change in Cognitive Function Score	DKEFS category fluency is an investigator administered test checking into ability to switch between categories presented. There is no upper limit on the D-KEFS measures. There is no lower limit on the D-KEPS measure. Higher scores reflect better verbal fluency. An increase in score from pre-post would indicate improvement. Decrease in value represents decrease in fluency. Raw score is total of Animals + Boys Names.	Screening to Day 13 (Visit 9)
Change in Cognitive Function Score	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.	Screening to Day 13 (Visit 9)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Vanessa Hinson, MD, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2018
• Primary Completion (Actual): June 15, 2021
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Estimate): January 24, 2023
• Last Update Submitted That Met QC Criteria: January 5, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 00073767

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No