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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

Tracking Information
First Submitted Date  ICMJE October 21, 2014
First Posted Date  ICMJE November 2, 2014
Last Update Posted Date January 11, 2022
Actual Study Start Date  ICMJE June 2013
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
  • 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)
  • Orthostatic Tolerance (Maximal tolerated time in upright position) [ Time Frame: [0-50 min] relative time from tilt ]
    Maximal tolerated time in upright position
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transdermal Vagal Stimulation for POTS
Official Title  ICMJE Transdermal Vagal Stimulation for the Treatment of Postural Tachycardia Syndrome
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Postural Orthostatic Tachycardia Syndrome
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.

    Interventions:
    • Other: Stimulation
    • Other: Placebo
  • 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.

    Interventions:
    • Other: Stimulation
    • Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 1, 2017)
18
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2014)
20
Estimated Study Completion Date  ICMJE December 2022
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02281097
Other Study ID Numbers  ICMJE VANDERBILT_IRB_121816
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: No. There is no plan to share data.
Current Responsible Party Andre' Diedrich, Vanderbilt University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vanderbilt University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andre Diedrich, MD, PhD Vanderbilt University
Principal Investigator: Italo Biaggioni, MD Vanderbilt University
PRS Account Vanderbilt University Medical Center
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP