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Could ear nerve stimulation calm racing hearts in POTS?

NCT ID NCT03124355

Disease control Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This pilot study investigates whether stimulating a nerve in the earlobe (vagal nerve stimulation), alone or combined with two medications (galantamine and pyridostigmine), can help control heart rate and reduce symptoms in women with Postural Tachycardia Syndrome (POTS). Participants undergo tilt-table tests while receiving different combinations of stimulation and drugs. The goal is to see if these approaches can improve how the autonomic nervous system manages heart rhythm during standing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcutaneous vagal nerve stimulation, galantamine, pyridostigmine
What this could lead to
If successful, this approach could point toward a non-drug or drug-combination therapy to help manage POTS symptoms and improve quality of life.
What could go wrong
This is a very small, early-phase pilot study with only 11 participants, so results may not apply broadly. The interventions may not produce meaningful benefits or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

11 people

The number who actually took part.

Started

Sep 2017

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female subjects of 18-45 years, with Postural Tachycardia Syndrome (POTS) as defined by a heart rate increase ≥30 bpm from supine within 10 min of standing or head-up tilt in the absence of orthostatic hypotension, with chronic symptoms (\> 6 months), and in the absence of other acute cause of orthostatic tachycardia. * Subjects able and willing to provide informed consent Exclusion Criteria: * Pregnancy. * Medical conditions that can explain postural tachycardia (e.g., dehydration, medications). * Patients who are bedridden or chair-ridden * Subjects taking any medication known to affect autonomic function or inflammatory markers (e.g. corticosteroids) who could not discontinue them before study participation. * Conditions associated with chronic inflammatory processes which in the investigator's opinion would affect the interpretation of the results. Examples may include smoking, diabetes, BMI\>30 kg/m2, current infections or cancer. * Other factors which in the investigator's opinion would prevent the subject from completing the protocol.

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Conditions

The condition(s) this trial relates to.

postural orthostatic tachycardia syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postural tachycardia syndrome

Contacts and locations

Locations

  • Autonomic Dysfunction Center/ Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

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