N/A N=33 Randomized Double-blind Treatment

taVNS in Mild to Moderate Parkinson's Disease

Parkinson Disease

Bottom Line

View on ClinicalTrials.gov: NCT04157621 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2023

Primary outcome: Primary: Change in Motor Function Score as Assessed by Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III — 0.72; 0.01 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Active taVNS (Device); Sham Stimulation (Device)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Motor Function Score as Assessed by Modified Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III	0.72; 0.01	—
SECONDARY Change in Cognitive Function Score	0.19; 0.70	—
SECONDARY Change in Cognitive Function Score	0.19; 0.70	—
SECONDARY Change in Cognitive Function Score	0.19; 0.70	—

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.

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
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04157621). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.