Clinical trial NCT02281097: Transdermal Vagal Stimulation for POTS
Official title: Transdermal Vagal Stimulation for the Treatment of Postural Tachycardia Syndrome
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postural Orthostatic Tachycardia Syndrome
Keywords: Postural Orthostatic Tachycardia Syndrome
POTS
Vagal Stimulation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2014-11-02
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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 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.

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* Subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure.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

Primary outcomes:
measure: Heart Rate (average of 1 minute)
timeFrame: [-5,0,5,10,15,20,..,50 min] relative time from tilt
Secondary outcomes:
measure: Orthostatic Symptoms (Subjective analog symptoms scale (0-100)
timeFrame: [-5,0,5,10,15,20,..,50 min] relative time from tilt
measure: Orthostatic Tolerance (Maximal tolerated time in upright position)
timeFrame: [0-50 min] relative time from tilt
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Autonomic Dysfunction Center, Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Andre Diedrich, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Italo Biaggioni, MD
role: PRINCIPAL_INVESTIGATOR
References: