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Active, Not Recruiting

NCT Number: NCT02281097

Transdermal Vagal Stimulation for POTS

Some patients experience high heart rates and symptoms of light-headedness, fatigue, headache during standing despite well maintained blood pressure.

These patient are disabled and can't be in upright position for a longer time. The purpose of this study is to test whether electrical stimulation of a nerve through a skin of the ear may improve heart rate response and reduce disabling symptoms.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Postural Orthostatic Tachycardia Syndrome Autonomic Nervous System Diseases Nervous System Diseases Orthostatic Intolerance Primary Dysautonomias

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Autonomic Dysfunction Center, Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2195, United States

About this study

Background Postural Tachycardia Syndrome (POTS) is a syndrome characterized by disabling symptoms of inadequate cerebral perfusion on assuming the upright posture, including light-headedness, fatigue, palpitations, altered mentation, headache, nausea, presyncope, and occasionally syncope.

POTS is characterized by an excessive increase in heart rate and exaggerated increase in plasma catecholamine levels on standing in the absence of a blood pressure fall. These disabling symptoms persist for more than six months.

Objective The objective of this study is to study the effect of vagal stimulation on heart rate modulation during supine and upright posture as a treatment modality for patients with POTS.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-smoking patients who qualify with the criteria of idiopathic postural tachycardia syndrome will be studied. The criteria are:
  • an increase of heart rate of 30 beats/minute or an upright heart rate of >= 120 bpm, and
  • chronic problems of symptoms during upright posture for at least 6 month.
  • Subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure.
  • The age limit is 18-75 years.

Exclusion criteria

  • Patients that have other major medical problems, such as cancer or heart disease are excluded because the influence of that diagnosis on the symptoms is not known.
  • Pregnancy.

Treatment and study plan

Stimulation

Other

Application of current to skin above auricular branch of vagal nerve to modulate heart rate and symptoms

Placebo

Other

Application of low intensive current or frequency to skin above auricular branch of vagal nerve as sham intervention

Primary outcomes

  1. Heart Rate (average of 1 minute)

    Time frame: [-5,0,5,10,15,20,..,50 min] relative time from tilt

    Upright heart rate and heart rate change from supine measured during graded tilt with 15 degrees increments each 5 minutes till 30 min of 75 degrees or abort.

Secondary outcomes

  1. Orthostatic Symptoms (Subjective analog symptoms scale (0-100)

    Time frame: [-5,0,5,10,15,20,..,50 min] relative time from tilt

    Subjective analog symptoms scale (0-100)

  2. Orthostatic Tolerance (Maximal tolerated time in upright position)

    Time frame: [0-50 min] relative time from tilt

    Maximal tolerated time in upright position

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

Transdermal Vagal Stimulation for the Treatment of Postural Tachycardia Syndrome

Important dates

Study start
2013
Primary completion
2017
Study completion
2026
First posted
Nov 3, 2014
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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