Using taVNS to Modulate Cardiovascular Function in Individuals With Neurologic Disease

NCT07557706 | Recruiting

• 2 other identifiers: 300014518UAB
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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)

Keywords

vagus nerve stimulation; neuromodulation; parkinson's disease

Outcome Measures

Primary Outcomes (2)

• Change in heart rate

  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

  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 Outcomes (5)

• Skin temperature

  Before, during and immediately after both active and sham taVNS.

• Autonomic Symptom Burden (COMPASS-31)

  Baseline (Visit 1)

• Autonomic Symptom Severity (SCOPA-AUT)

  Baseline (Visit 1)

• Physical Activity (Goodin Leisure-Time Exercise Questionnaire)

  Baseline (Visit 1)

• Physical Activity (International Physical Activity Questionnaire)

  Baseline (Visit 1)

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

EXPERIMENTAL

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

Interventions

transcutaneous auricular vagus nerve stimulation DEVICE

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.

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of idiopathic PD
• Stable medication for at least 4 weeks prior to the study

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Wellness, Health and Research Facility at UAB

Birmingham, Alabama, 35209, United States

RECRUITING

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Alexandra Evancho, DPT

CONTACT

205-975-5221; amelgin@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: April 29, 2026
• Study Start: September 15, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)