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Transdermal Vagal Stimulation for POTS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02281097
Recruitment Status : Active, not recruiting
First Posted : November 2, 2014
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Andre' Diedrich, Vanderbilt University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Postural Orthostatic Tachycardia Syndrome Other: Stimulation Other: Placebo Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Transdermal Vagal Stimulation for the Treatment of Postural Tachycardia Syndrome
Actual Study Start Date : June 2013
Actual Primary Completion Date : April 2017
Estimated Study Completion Date : December 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.

 Other: Stimulation
Application of current to skin above auricular branch of vagal nerve to modulate heart rate and symptoms

Other: Placebo
Application of low intensive current or frequency to skin above auricular branch of vagal nerve as sham intervention
Placebo Comparator: 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.

 Other: Stimulation
Application of current to skin above auricular branch of vagal nerve to modulate heart rate and symptoms

Other: Placebo
Application of low intensive current or frequency to skin above auricular branch of vagal nerve as sham intervention


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Orthostatic Symptoms (Subjective analog symptoms scale (0-100) [ Time Frame: [-5,0,5,10,15,20,..,50 min] relative time from tilt ]
    Subjective analog symptoms scale (0-100)

  2. Orthostatic Tolerance (Maximal tolerated time in upright position) [ Time Frame: [0-50 min] relative time from tilt ]
    Maximal tolerated time in upright position


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02281097


Locations
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United States, Tennessee
Autonomic Dysfunction Center, Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37232-2195
Sponsors and Collaborators
Vanderbilt University
Investigators
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Principal Investigator: Andre Diedrich, MD, PhD Vanderbilt University
Principal Investigator: Italo Biaggioni, MD Vanderbilt University
More Information
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Additional Information:

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Responsible Party: Andre' Diedrich, Research Professor of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02281097    
Other Study ID Numbers: VANDERBILT_IRB_121816
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No. There is no plan to share data.
Keywords provided by Andre' Diedrich, Vanderbilt University:
Postural Orthostatic Tachycardia Syndrome
POTS
Vagal Stimulation
Additional relevant MeSH terms:
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Postural Orthostatic Tachycardia Syndrome
Tachycardia
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases