Recruiting
Phase 1

taVNS

Sponsor:

University of Alabama at Birmingham

Code:

NCT07557706

Conditions

PARKINSON DISEASE (Disorder)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

transcutaneous auricular vagus nerve stimulation

Study Details

Brief summary:

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.

Conditions

PARKINSON DISEASE (Disorder)

Study ID

NCT07557706

Start date

Sep 15, 2025

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Group 1

Active taVNS on Visit 2, Sham taVNS on Visit 3. Active taVNS is delivered at 30 Hz, 250 µs, 0.1-4 mA for 15 minutes. Sham taVNS is delivered at 0 mA output for 15 minutes. A minimum washout period of 48 hours will be observed between visits.

experimental: Group 2

Sham taVNS on Visit 2, Active taVNS on Visit 3. Active taVNS is delivered at 30 Hz, 250 µs, 1-4 mA for 15 minutes. Sham taVNS is delivered at 0 mA output for 15 minutes. A minimum washout period of 48 hours will be observed between visits

Interventions

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 measure

  • 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. ]

Central Contacts and Locations

Central contacts

Alexandra Evancho, DPT

205-975-5221amelgin@uab.edu

Locations

Wellness, Health and Research Facility at UAB

Recruiting

Birmingham, Alabama, United States, 35209

Contacts

Alex Evancho

205-975-5221amelgin@uab.edu

Principal Investigator:

Alex Evancho, DPT

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • vagus nerve stimulation
  • neuromodulation
  • parkinson's disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-06-18.