Postural Orthostatic Tachycardia Syndrome
Conditions
Keywords
Postural Orthostatic Tachycardia Syndrome, POTS, Vagal Stimulation
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.
Interventions
OTHERStimulation
Application of current to skin above auricular branch of vagal nerve to modulate heart rate and symptoms
OTHERPlacebo
Application of low intensive current or frequency to skin above auricular branch of vagal nerve as sham intervention
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 * Subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure.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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate (average of 1 minute) | [-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
| Measure | Time frame | Description |
|---|---|---|
| Orthostatic Symptoms (Subjective analog symptoms scale (0-100) | [-5,0,5,10,15,20,..,50 min] relative time from tilt | Subjective analog symptoms scale (0-100) |
| Orthostatic Tolerance (Maximal tolerated time in upright position) | [0-50 min] relative time from tilt | Maximal tolerated time in upright position |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAndre Diedrich, MD, PhD
Vanderbilt University Medical Center
PRINCIPAL_INVESTIGATORItalo Biaggioni, MD
Vanderbilt University Medical Center
Outcome results
None listed