Transdermal Vagal Stimulation for the Treatment of Postural Tachycardia Syndrome
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postural Orthostatic Tachycardia Syndrome
- Sponsor
- Vanderbilt University
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Heart Rate (average of 1 minute)
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
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.
Investigators
Andre' Diedrich
Research Professor of Medicine
Vanderbilt University
Eligibility Criteria
Inclusion Criteria
- •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- •Subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure.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.
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.
Outcomes
Primary Outcomes
Heart Rate (average of 1 minute)
Time Frame: [-5,0,5,10,15,20,..,50 min] relative time from tilt
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.
Secondary Outcomes
- Orthostatic Tolerance (Maximal tolerated time in upright position)([0-50 min] relative time from tilt)
- Orthostatic Symptoms (Subjective analog symptoms scale (0-100)([-5,0,5,10,15,20,..,50 min] relative time from tilt)