N/A
Completed N=33
taVNS in Mild to Moderate Parkinson's Disease
Source: ClinicalTrials.gov NCT04157621 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jan 2023
Primary outcomePrimary: 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
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.
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 | — |
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
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. Informational only — not medical advice.