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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stimulation | Other | Application of current to skin above auricular branch of vagal nerve to modulate heart rate and symptoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Orthostatic Symptoms (Subjective analog symptoms scale (0-100) | 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) |
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Inclusion Criteria:
Non-smoking patients who qualify with the criteria of idiopathic postural tachycardia syndrome will be studied. The criteria are:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Andre Diedrich, MD, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Italo Biaggioni, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Autonomic Dysfunction Center, Vanderbilt University Medical Center | Nashville | Tennessee | 37232-2195 | United States |
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| Label | URL |
|---|---|
| Vanderbilt Autonomic Dysfunction Center | View source |
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No. There is no plan to share data.
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| ID | Term |
|---|---|
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Placebo | Other | Application of low intensive current or frequency to skin above auricular branch of vagal nerve as sham intervention |
|
Maximal tolerated time in upright position
| [0-50 min] relative time from tilt |