Autoimmune Basis for Postural Tachycardia Syndrome | NCT05043051

Studies
Autoimmune Basis for Postural Tachycardia Syndrome

NCT05043051

Sponsor

University of Oklahoma

Status

Active, not recruiting

Last Update Posted

Apr 8, 2026Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Postural Tachycardia Syndrome

Interventions

Vagal stimulation
Sham stimulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2R01HL128393-04	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2022Actual

Primary Completion Date

Feb 28, 2026Actual

Completion Date

Jul 31, 2026Estimated

First Submitted Date

Aug 27, 2021

First Submission Date that Met QC Criteria

Sep 8, 2021

First Posted Date

Sep 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2026

Last Update Posted Date

Apr 8, 2026Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vagal stimulation	Active Comparator	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
Sham stimulation	Sham Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vagal stimulation	Device	Vagal stimulation	Vagal stimulation	Transcutaneous electrical nerve stimulation

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Stavros Stavrakis, MD	University of Oklahoma	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Oklahoma Clinical and Translational Science Institute		Oklahoma City	Oklahoma	73104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37999672	Derived	Stavrakis S, Chakraborty P, Farhat K, Whyte S, Morris L, Abideen Asad ZU, Karfonta B, Anjum J, Matlock HG, Cai X, Yu X. Noninvasive Vagus Nerve Stimulation in Postural Tachycardia Syndrome: A Randomized Clinical Trial. JACC Clin Electrophysiol. 2024 Feb;10(2):346-355. doi: 10.1016/j.jacep.2023.10.015. Epub 2023 Nov 22.

ID	Term
D054971	Orthostatic Intolerance
D054969	Primary Dysautonomias
D001342	Autonomic Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D055536	Vagus Nerve Stimulation
D004561	Transcutaneous Electric Nerve Stimulation

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics
D026741	Physical Therapy Modalities
D012046	Rehabilitation