Ear vagus nerve stimulation to improve heart rate and blood pressure control in Parkinson's disease
Using taVNS to Modulate Cardiovascular Function in Individuals With Neurologic Disease
This study will see if gentle ear-based vagus nerve stimulation can help people with Parkinson's disease better control their heart rate and blood pressure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT07557706 on ClinicalTrials.gov |
What this trial studies
This interventional trial uses transcutaneous auricular vagus nerve stimulation (taVNS), a non-invasive ear stimulation, to modulate autonomic control in people with Parkinson's disease. Participants on stable Parkinson's medications will receive taVNS while investigators measure heart rate and blood pressure responses under controlled conditions. People with significant cardiac disease, active arrhythmias, recent major cardiac events, seizure disorders, severe cognitive impairment, or on beta blockers are excluded to reduce risk and confounding. The study aims to determine whether taVNS can acutely or in the short term improve cardiovascular regulation and thereby support physical function.
Who should consider this trial
Good fit: Adults with idiopathic Parkinson's disease who are on stable medications, not taking beta blockers, without major uncontrolled cardiac disease, and able to travel to the study site are the ideal candidates.
Not a fit: People with uncontrolled hypertension, significant arrhythmias, heart failure, recent myocardial infarction, seizure disorders, severe cognitive impairment, those taking beta blockers, or who are pregnant are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, taVNS could improve day-to-day blood pressure and heart-rate control, making exercise and daily activities safer and easier for people with Parkinson's disease.
How similar studies have performed: Small prior studies of taVNS have shown changes in autonomic measures, but clear clinical benefit for Parkinson's-related cardiovascular dysfunction has not been established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of idiopathic PD * Stable medication for at least 4 weeks prior to the study Exclusion Criteria: * Use of beta blockers * Sustained severe hypertension (\>/= 180/110 mmHg while seated) * Significant uncontrolled cardiac arrhythmia * Unstable angina * Congestive heart failure * History of myocardial infarction * History of seizures * Severe cognitive impairment * Pregnant women or women who are planning to become pregnant
Where this trial is running
Birmingham, Alabama
- Wellness, Health and Research Facility at UAB — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Alexandra Evancho, DPT
- Email: amelgin@uab.edu
- Phone: 205-975-5221
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.