Transdermal Vagal Stimulation for POTS

Vanderbilt University

Status: Active, not recruiting

Conditions: Postural Orthostatic Tachycardia Syndrome

Treatments: Other: Stimulation; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02281097

VANDERBILT_IRB_121816

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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• Subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure.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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

Vagal Stimulation First

Active Comparator group

Description:

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.

Treatment:

Other: Placebo

Other: Stimulation

Placebo First

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Other: Stimulation