NCT02281097

Transdermal Vagal Stimulation for POTS

Transdermal Vagal Stimulation for the Treatment of Postural Tachycardia Syndrome

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Postural Orthostatic Tachycardia Syndrome

Interventions

Type	Name	Description
OTHER	Stimulation	Application of current to skin above auricular branch of vagal nerve to modulate heart rate and symptoms
OTHER	Placebo	Application of low intensive current or frequency to skin above auricular branch of vagal nerve as sham intervention

Timeline

• Start date: 2013-06-01
• Primary completion: 2017-04-01
• Completion: 2026-12-31
• First posted: 2014-11-03
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States