Transdermal Vagal Stimulation for POTS

NCT02281097 | Active Not Recruiting

• 1 other identifier: VANDERBILT_IRB_121816
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Orthostatic Tachycardia Syndrome

Keywords

Postural Orthostatic Tachycardia Syndrome; POTS; Vagal Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Orthostatic Symptoms (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)

  [0-50 min] relative time from tilt

Study Arms (2)

Vagal Stimulation First

ACTIVE COMPARATOR

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; Other: Placebo

Placebo First

PLACEBO COMPARATOR

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; Other: Placebo

Interventions

Stimulation OTHER

Application of current to skin above auricular branch of vagal nerve to modulate heart rate and symptoms

Placebo First; Vagal Stimulation First

Placebo OTHER

Application of low intensive current or frequency to skin above auricular branch of vagal nerve as sham intervention

Placebo First; Vagal Stimulation First

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-smoking patients who qualify with the criteria of idiopathic postural tachycardia syndrome will be studied. The criteria are:
• an increase of heart rate of 30 beats/minute or an upright heart rate of \>= 120 bpm, and
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Autonomic Dysfunction Center, Vanderbilt University Medical Center

Nashville, Tennessee, 37232-2195, United States

Location

Related Links

• Vanderbilt Autonomic Dysfunction Center

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Study Officials

• Andre Diedrich, MD, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Italo Biaggioni, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor of Medicine

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: November 3, 2014
• Study Start: June 1, 2013
• Primary Completion: April 1, 2017
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)