taVNS in Mild to Moderate Parkinson's Disease

NCT04157621 | Completed Results FDA Device

• 1 other identifier: 00073767
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Cognitive Function Score

  Screening to Day 13 (Visit 9)

• Change in Cognitive Function Score

  Screening to Day 13 (Visit 9)

• Change in Cognitive Function Score

  Screening to Day 13 (Visit 9)

Study Arms (2)

Active taVNS

ACTIVE COMPARATOR

Device: Active taVNS

Sham Stimulation

SHAM COMPARATOR

Device: Sham Stimulation

Interventions

Active taVNS DEVICE

Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus

Active taVNS

Sham Stimulation DEVICE

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.

Sham Stimulation

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Vanessa Hinson
• Organization: MUSC

hinsonvk@musc.edu

843-876-0829

Study Officials

• Vanessa Hinson, MD, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Program Director

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: November 8, 2019
• Study Start: March 20, 2018
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: January 25, 2023
• Results First Posted: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)