NCT07557706 · University of Alabama at Birmingham
Using taVNS to Modulate Cardiovascular Function in Individuals With Neurologic Disease
What this study is about
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.
View original scientific description
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.
Assessment of how the body adjusts heart rate during taVNS and during physical challenges. Tests include the Valsalva maneuver (blowing into a mouthpiece for 15 seconds), deep breathing test (breathing deeply and evenly at a rate of 6 breaths/minute), lying-to-standing heart rate and blood pressure tests, and an isometric handgrip test (sustaining a handgrip contraction on a dynamometer at 30% maximal effort for 5 minutes). Heart rate is continuously monitored using a Polar HR monitor.
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.
Assessment of how the body adjusts blood pressure during taVNS and during physical challenges. Tests include the Valsalva maneuver (blowing into a mouthpiece for 15 seconds), deep breathing test (breathing deeply and evenly at a rate of 6 breaths/minute), lying-to-standing heart rate and blood pressure tests, and an isometric handgrip test (sustaining a handgrip contraction on a dynamometer at 30% maximal effort for 5 minutes). Blood pressure is measured manually using a sphygmomanometer.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Birmingham, Alabama
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 18, 2026 · Source of record for eligibility and locations