Clinical Trial: Transdermal Vagal Stimulation for POTS

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Transdermal Vagal Stimulation for the Treatment of Postural Tachycardia Syndrome

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Vanderbilt University

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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)
  • Orthostatic Tolerance (Maximal tolerated time in upright position) [ Time Frame: [0-50 min] relative time from tilt ]
    Maximal tolerated time in upright position


Original Secondary Outcome: Same as current

Information By: Vanderbilt University Medical Center

Dates:
Date Received: October 21, 2014
Date Started: June 2013
Date Completion: December 2017
Last Updated: January 13, 2017
Last Verified: January 2017