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PARKINSON DISEASE (Disorder)Phase 1NCT07557706

Using taVNS to Modulate Cardiovascular Function in Individuals With Neurologic Disease

A Phase 1 study testing transcutaneous auricular vagus nerve stimulation in people with PARKINSON DISEASE (Disorder), run by University of Alabama at Birmingham at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
PARKINSON DISEASE (Disorder)
What is being tested?
transcutaneous auricular vagus nerve stimulation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
15 Sep 2025to 31 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 9Show fewer
  • History of seizures
  • Severe cognitive impairment
  • Pregnant women or women who are planning to become pregnant

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alexandra Evancho, DPT contact

205-975-5221

amelgin@uab.edu

United States1 site, 1 recruiting

  • Wellness, Health and Research Facility at UAB

    Birmingham, Alabama, 35209

    Alex Evancho, 205-975-5221, amelgin@uab.edu

    Alex Evancho, DPT

    Recruiting

Other trials in United States

About this study

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.

Being tested
transcutaneous auricular vagus nerve stimulation
Keywords
vagus nerve stimulation, neuromodulation, parkinson's disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transcutaneous auricular vagus nerve stimulationDevice

    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.

Study groups in NCT07557706
Study groupRoleWhat they receive
Group 1ExperimentalActive 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.
Receives: Device: transcutaneous auricular vagus nerve stimulation
Group 2ExperimentalSham 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
Receives: Device: transcutaneous auricular vagus nerve stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

  2. 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.

    Measured: 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)

  1. Skin temperature

    Infrared thermography will be used to assess facial, hand, and foot skin temperature.

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

  2. Autonomic Symptom Burden (COMPASS-31)

    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).

    Measured: Baseline (Visit 1)

  3. Autonomic Symptom Severity (SCOPA-AUT)

    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).

    Measured: Baseline (Visit 1)

  4. Physical Activity (Goodin Leisure-Time Exercise Questionnaire)

    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".

    Measured: Baseline (Visit 1)

  5. Physical Activity (International Physical Activity Questionnaire)

    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.

    Measured: Baseline (Visit 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2026
  2. Study start15 Sep 2025
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07557706
Sponsor's protocol ID
300014518
Other IDs
UAB
Status last verified
Jun 2026
First submitted
17 Mar 2026
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 41557119

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing transcutaneous auricular vagus nerve stimulation in people with PARKINSON DISEASE (Disorder), run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexandra Evancho, DPT (205-975-5221, amelgin@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07557706, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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