taVNS in Mild to Moderate Parkinson's Disease

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: Active taVNS; Device: Sham Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04157621

00073767

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 40 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups

Active taVNS

Active Comparator group

Treatment:

Device: Active taVNS

Sham Stimulation

Sham Comparator group

Treatment:

Device: Sham Stimulation