Transdermal Vagal Stimulation for POTS

N/AActive Not RecruitingNCT02281097

Vanderbilt University18 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

StimulationOTHER

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

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Non-smoking patients who qualify with the criteria of idiopathic postural tachycardia syndrome will be studied. The criteria are: 1. an increase of heart rate of 30 beats/minute or an upright heart rate of \>= 120 bpm, and 2. 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 * Subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure.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.

Locations (1)

Autonomic Dysfunction Center, Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Heart Rate (average of 1 minute)

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.

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

Secondary Outcomes

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

Subjective analog symptoms scale (0-100)

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

Orthostatic Tolerance (Maximal tolerated time in upright position)

Maximal tolerated time in upright position

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

Data from ClinicalTrials.gov

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