Using taVNS to Modulate Cardiovascular Function in Individuals With Neurologic Disease

June 16, 2026 updated by: Alexandra Evancho, University of Alabama at Birmingham
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Alexandra Evancho, DPT
  • Phone Number: 205-975-5221
  • Email: amelgin@uab.edu

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Recruiting
        • Wellness, Health and Research Facility at UAB
        • Contact:
        • Principal Investigator:
          • Alex Evancho, DPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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

Outcome Measure
Measure Description
Time Frame
Skin temperature
Time Frame: Before, during and immediately after both active and sham taVNS.
Infrared thermography will be used to assess facial, hand, and foot skin temperature.
Before, during and immediately after both active and sham taVNS.
Autonomic Symptom Burden (COMPASS-31)
Time Frame: Baseline (Visit 1)
The Composite Autonomic Symptom Score 31 (COMPASS-31) is a validated, self-assessment questionnaire used to evaluate the severity and distribution of autonomic nervous system symptoms.Scores from each domain are weighted and summed to calculate a final Total Score. The Total Score ranges from 0 to 100. A higher score indicates a greater severity and wider distribution of autonomic symptoms (worse autonomic function), while a lower score indicates fewer and less severe autonomic symptoms (better autonomic function).
Baseline (Visit 1)
Autonomic Symptom Severity (SCOPA-AUT)
Time Frame: Baseline (Visit 1)

The Scales for Outcomes in Parkinson's disease - Autonomic Dysfunction (SCOPA-AUT) is a self-administered questionnaire specifically developed to assess autonomic symptoms in individuals with Parkinson's disease. The questionnaire evaluates the frequency of problems experienced over the past month.

Each item is scored on a 4-point Likert scale ranging from 0 ("never") to 3 ("often"). The Total Score is calculated by summing the responses of the 23 applicable items, with a possible range from 0 to 69. A higher score indicates a greater frequency and severity of autonomic dysfunction (worse autonomic functioning), while a lower score indicates fewer autonomic symptoms (better autonomic functioning).
Baseline (Visit 1)
Physical Activity (Goodin Leisure-Time Exercise Questionnaire)
Time Frame: Baseline (Visit 1)

The Godin Leisure-Time Exercise Questionnaire (GLTEQ) is a brief, validated self-report instrument that assesses an individual's usual physical activity habits over a typical 7-day period.

The questionnaire consists of 3 items asking participants to report the number of times per week they engage in physical activities lasting more than 15 minutes across three specific intensity levels. The Weekly Leisure-Time Activity Score is calculated by multiplying the reported weekly frequencies by their respective Metabolic Equivalent (MET) values and summing the results using the following formula: (9 x Strenuous) + (5 x Moderate) + (3 x Light).

The minimum possible score is 0, and there is no theoretical maximum upper limit. A higher score indicates a greater volume and intensity of weekly physical activity (better physical activity level). Clinically, a score of 24 or higher is classified as "Active," 14 to 23 as "Moderately Active," and less than 14 as "Insufficiently Active/Sedentary".
Baseline (Visit 1)
Physical Activity (International Physical Activity Questionnaire)
Time Frame: Baseline (Visit 1)

The International Physical Activity Questionnaire - Short Form (IPAQ-SF) is a validated self-report instrument used to estimate total physical activity and time spent sitting over the preceding 7 days.

The questionnaire consists of 7 open-ended questions asking participants to recall the number of days per week and the amount of time usually spent per day engaged in specific intensities of physical activity lasting at least 10 minutes.

Data are used to calculate the total physical activity expressed in Metabolic Equivalent of Task (MET)-minutes per week. The total MET-minutes/week is calculated by weighting the reported minutes per week for each activity category by a standard MET energy expenditure estimate (Walking = 3.3 METs, Moderate = 4.0 METs, Vigorous = 8.0 METs) and summing the values. The minimum possible score is 0, and there is no theoretical maximum upper limit. A higher MET-minutes/week score indicates a greater volume of physical activity.
Baseline (Visit 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 17, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 18, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 300014518
  • UAB (Other Identifier: UAB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on PARKINSON DISEASE (Disorder)

Clinical Trials on transcutaneous auricular vagus nerve stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe