Using taVNS to Modulate Cardiovascular Function in Individuals With Neurologic Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: transcutaneous auricular vagus nerve stimulation.
- Who it may be relevant to
- Registry conditions: PARKINSON DISEASE (Disorder). Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to find out whether a type of gentle nerve stimulation, called transcutaneous auricular Vagus Nerve Stimulation (taVNS), can help improve how the body regulates heart rate and blood pressure in people with Parkinson's Disease (PD). Problems with heart rate and blood pressure control are common and can make it harder for people to exercise or do daily activities. By using this non-invasive form of nerve stimulation and testing how it affects the body's natural responses, this study hopes to learn if taVNS could be a helpful tool to support physical therapy and improve overall function.
Interventions
- Device transcutaneous auricular vagus nerve stimulation
Participants will sit quietly while receiving active nerve stimulation for 15 minutes. A gentle electrical current is delivered through hydrogel electrodes placed in the ear. The active stimulation parameters are set to 30 Hz, 250 µs, and 0.1-4 mA.
Primary outcome measures
- Change in heart rate [Time frame: During Visit 2 and Visit 3 (1-2 weeks after baseline, with 48 hour wash-out between visits 2 and 3), during and following 15 minutes of stimulation.]
- Change in blood pressure [Time frame: During Visit 2 and Visit 3 (1-2 weeks after baseline, with 48 hour wash-out between visits 2 and 3), during and following 15 minutes of stimulation.]
Secondary outcome measures (5)
- Skin temperature [Time frame: Before, during and immediately after both active and sham taVNS.]
- Autonomic Symptom Burden (COMPASS-31) [Time frame: Baseline (Visit 1)]
- Autonomic Symptom Severity (SCOPA-AUT) [Time frame: Baseline (Visit 1)]
- Physical Activity (Goodin Leisure-Time Exercise Questionnaire) [Time frame: Baseline (Visit 1)]
- Physical Activity (International Physical Activity Questionnaire) [Time frame: Baseline (Visit 1)]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Other
Study locations
United States · 1 center
- Wellness, Health and Research Facility at UAB — Birmingham
Publications
- Barkoula TR, Ioannou C, Rekatsina M, Theodoraki K, Zis P. Cutoffs, sensitivity and specificity of the Ewing battery in evaluating autonomic nervous system disorders: a systematic review. Clin Auton Res. 2026 Apr;36(2):155-173. doi: 10.1007/s10286-025-01185-x. Epub 2026 Jan 20. PMID 41557119
Identifiers
NCT: NCT07557706 · 300014518 · UAB