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Vagus Nerve Stimulation in Treatment of Postural Orthostatic Tachycardia Syndrome

NCT03930914 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-12-18

No results posted yet for this study

Summary

Postural orthostatic tachycardia (POTS) is characterized by abnormalities in the autonomic nervous system in the body. The autonomic nervous system controls and regulates body functions such as heart rate, breathing, digestion, and more.

The investigator has shown that patients with POTS have higher cardiovascular and adrenergic activating autoantibodies (AAb), which likely changes the normal make-up of POTS. There are autoantibodies that have been suggested by a few reports of their presence in POTS, but their role different aspects of POTS is unknown. The study will look at the body's responses in patients with POTS. The crossover study design is to have half of the patients will start with sham followed by active stimulation and half will start by active followed by sham stimulation. It is anticipated that results will provide a potential therapeutic approach based on the understanding of POTS.

Conditions

  • Postural Orthostatic Tachycardia Syndrome

Interventions

DEVICE

Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device

Daily use of Parasym (TM) device on tragus or ear lobe, as assigned treatment arm

Sponsors & Collaborators

  • Dysautonomia International

    collaborator OTHER

  • University of Oklahoma

    lead OTHER

Principal Investigators

  • Xichun Yu, MD · University of Oklahoma

  • Stavros Stavrakis, MD · University of Oklahoma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2020-03-02
Completion
2021-12-07

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03930914 on ClinicalTrials.gov