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 ]
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