Transdermal Vagal Stimulation for POTS

Transdermal Vagal Stimulation for the Treatment of Postural Tachycardia Syndrome

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Postural Orthostatic Tachycardia Syndrome
• Intervention / Treatment: Other: Stimulation; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-2195
      • Autonomic Dysfunction Center, Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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• Subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure.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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vagal Stimulation First; Vagal stimulation to improve upright heart rate modulation and symptoms is given on first tilt study day. Placebo stimulation with ineffective low amplitude and frequency (sham intervention) is given on second tilt study.	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
Placebo Comparator: Placebo First; Placebo stimulation with ineffective low amplitude and frequency (sham intervention) is given on first tilt study day. Vagal stimulation to improve upright heart rate modulation and symptoms is given on second tilt study day.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Andre Diedrich, MD, PhD, Vanderbilt University Medical Center; Principal Investigator: Italo Biaggioni, MD, Vanderbilt University Medical Center

Publications and helpful links

Helpful Links

• Vanderbilt Autonomic Dysfunction Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2013
• Primary Completion (Actual): April 1, 2017
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimated): November 2, 2014

Study Record Updates

• Last Update Posted (Actual): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 25, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: POTS; Postural Orthostatic Tachycardia Syndrome; Vagal Stimulation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Nervous System Diseases; Disease; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Syndrome; Tachycardia; Postural Orthostatic Tachycardia Syndrome
• Other Study ID Numbers: VANDERBILT_IRB_121816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No. There is no plan to share data.