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Could POTS be an autoimmune disease? new study tests nerve stimulation as a treatment

NCT ID NCT05043051

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jul 30, 2026 · Updated 3 times

Summary

This study looks at whether postural tachycardia syndrome (POTS) is caused by an autoimmune reaction. Researchers are testing if electrical stimulation of the vagus nerve can improve symptoms, reduce inflammation, and calm the immune system. The study includes 80 people with POTS and healthy volunteers to better understand the condition.

What this could mean

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

Active substance
Vagal stimulation (transcutaneous electrical nerve stimulation)
What this could lead to
If successful, this could point toward a new treatment for POTS by targeting the immune system and using nerve stimulation to reduce symptoms.
What could go wrong
This is an early-stage study focused on understanding the cause of POTS, not a treatment trial. The nerve stimulation approach may not work for everyone, and results may not lead to a proven therapy.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

80 people

The number who actually took part.

Started

Jan 2022

Finished

Jul 2026

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 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * 18-80 years old, female or male * Either healthy control or individual with postural tachycardia syndrome (POTS) defined as heart rate increase \>30 bpm from supine within 10 min of standing, in the absence of orthostatic hypotension (\>20/10 mmHg fall in blood pressure), with chronic symptoms (\>6 months), and in the absence of other acute cause of orthostatic tachycardia * Able and willing to provide informed consent * Understand and be able to comply with the study procedures and restrictions Exclusion Criteria: * Hypertension (\>150 mmHg systolic and \>100 mmHg diastolic) based on history or findings at screening * Orthostatic hypotension (consistent drop in blood pressure \>20/10 mmHg with 10 min of standing) * Cardiovascular disease, such as myocardial infarction within 6 months * History or presence of significant immunological or hematological disorders * History of vagotomy * Currently pregnant women or women planning on becoming pregnant ≤ 3 months * Inability to comply with the protocol * Patients with active implants (such as a cardiac pacemaker, or a cochlear implant) Healthy control subjects will be healthy, non-smoking and on no chronic medications at the time of the study. Healthy control subjects will be group-matched to the POTS patients for age and gender.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Oklahoma Clinical and Translational Science Institute

    Oklahoma City, Oklahoma, 73104, United States

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