Autoimmune Basis for Postural Tachycardia Syndrome

April 2, 2026 updated by: University of Oklahoma
The purpose of this study is to test the hypothesis that an antibody-mediated autoimmune reaction will cause symptoms of autonomic dysfunction in some patients with postural tachycardia syndrome (POTS). The investigators further hypothesize that electrical stimulation of the vagus nerve will improve POTS symptoms, autoimmunity and inflammation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The present study is designed to test the hypothesis that muscarinic autoantibody-mediated parasympathetic dysfunction contributes to the pathogenesis of POTS, and that parasympathetic (vagal) stimulation improves POTS symptoms, autoimmunity and inflammation.

Define and determine the prevalence, burden, and clinical significance of muscarinic autoantibodies in a well-phenotyped cohort of POTS patients with and without gastroparesis and a matched cohort of healthy control subjects.

Evaluate the impact of vagal stimulation on antibody suppression, inflammatory inhibition, and symptom improvement in POTS patients. Non-invasive transcutaneous stimulation of the auricular branch of the vagus nerve (tragus stimulation) will be used to increase parasympathetic activity.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Oklahoma Clinical and Translational Science Institute

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

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: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Vagal stimulation
Vagal stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the tragus for 2 months.
Device: Vagal stimulation
Vagal stimulation
Other Names:
  • Transcutaneous electrical nerve stimulation
Sham Comparator: Sham stimulation
Sham stimulation will be given at 20 Hz for 1 hour daily with the bipolar electrode attached to the earlobe for 2 months.
Device: Sham stimulation
Sham vagal stimulation
Other Names:
  • Transcutaneous electrical nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: 5 minute
Average of heart rate variability during the posture test
5 minute

Collaborators and Investigators

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

Sponsor

University of Oklahoma

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Study Director: Stavros Stavrakis, MD, University of Oklahoma

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)

January 14, 2022

Primary Completion (Actual)

February 28, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

September 8, 2021

First Posted (Actual)

September 13, 2021

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13705
  • 2R01HL128393-04 (U.S. NIH Grant/Contract)

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

product manufactured in and exported from the U.S.

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.

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