Transdermal Vagal Stimulation for POTS

Postural Orthostatic Tachycardia Syndrome Clinical Trial

Official title:

Transdermal Vagal Stimulation for the Treatment of Postural Tachycardia Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02281097
• Other study ID #: VANDERBILT_IRB_121816
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2013
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: December 2025
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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• Subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure.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.

Related Conditions & MeSH terms

• Postural Orthostatic Tachycardia Syndrome
• Syndrome
• Tachycardia

Intervention

Other:
• Stimulation
Application of current to skin above auricular branch of vagal nerve to modulate heart rate and symptoms
• Placebo
Application of low intensive current or frequency to skin above auricular branch of vagal nerve as sham intervention

Locations

Country	Name	City	State
United States	Autonomic Dysfunction Center, Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	[-5,0,5,10,15,20,..,50 min] relative time from tilt
Secondary	Orthostatic Symptoms (Subjective analog symptoms scale (0-100)	Subjective analog symptoms scale (0-100)	[-5,0,5,10,15,20,..,50 min] relative time from tilt
Secondary	Orthostatic Tolerance (Maximal tolerated time in upright position)	Maximal tolerated time in upright position	[0-50 min] relative time from tilt

External Links

•   Vanderbilt Autonomic Dysfunction Center