Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
18 participants
INTERVENTIONAL
2013-06-30
2025-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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Vagal Stimulation First
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.
Stimulation
Application of current to skin above auricular branch of vagal nerve to modulate heart rate and symptoms
Placebo
Application of low intensive current or frequency to skin above auricular branch of vagal nerve as sham intervention
Placebo First
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.
Stimulation
Application of current to skin above auricular branch of vagal nerve to modulate heart rate and symptoms
Placebo
Application of low intensive current or frequency to skin above auricular branch of vagal nerve as sham intervention
Interventions
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Stimulation
Application of current to skin above auricular branch of vagal nerve to modulate heart rate and symptoms
Placebo
Application of low intensive current or frequency to skin above auricular branch of vagal nerve as sham intervention
Eligibility Criteria
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Inclusion Criteria
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
* Pregnancy.
18 Years
75 Years
ALL
No
Sponsors
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Vanderbilt University
OTHER
Responsible Party
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Andre' Diedrich
Research Professor of Medicine
Principal Investigators
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Andre Diedrich, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Italo Biaggioni, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Autonomic Dysfunction Center, Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Related Links
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Vanderbilt Autonomic Dysfunction Center
Other Identifiers
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VANDERBILT_IRB_121816
Identifier Type: -
Identifier Source: org_study_id
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