NCT05043051

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Jan 2022Jul 2026

First Submitted

Initial submission to the registry

August 27, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

January 14, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Expected
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

August 27, 2021

Last Update Submit

April 2, 2026

Conditions

Postural Tachycardia Syndrome

Keywords

POTSVagal StimulationAutoantibody

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability

    Average of heart rate variability during the posture test

    5 minute

Study Arms (2)

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

Vagal stimulationDEVICE

Vagal stimulation

Also known as: Transcutaneous electrical nerve stimulation
Vagal stimulation
Sham stimulationDEVICE

Sham vagal stimulation

Also known as: Transcutaneous electrical nerve stimulation
Sham stimulation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oklahoma Clinical and Translational Science Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

  • 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.

    PMID: 37999672DERIVED

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Vagus Nerve StimulationTranscutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Stavros Stavrakis, MD

    University of Oklahoma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 13, 2021

Study Start

January 14, 2022

Primary Completion

February 28, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)