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Transdermal Vagal Stimulation for POTS

Primary Purpose

Postural Orthostatic Tachycardia Syndrome

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stimulation

Placebo

About this trial

This is an interventional other trial for Postural Orthostatic Tachycardia Syndrome focused on measuring Postural Orthostatic Tachycardia Syndrome, POTS, Vagal Stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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Subjects must also be able to safely withdrawn from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure.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.

Sites / Locations

Autonomic Dysfunction Center, Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vagal Stimulation First

Placebo First

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Orthostatic Symptoms (Subjective analog symptoms scale (0-100)

Subjective analog symptoms scale (0-100)

Orthostatic Tolerance (Maximal tolerated time in upright position)

Maximal tolerated time in upright position

Full Information

NCT ID

NCT02281097

First Posted

October 21, 2014

Last Updated

January 18, 2023

Sponsor

Vanderbilt University

1. Study Identification

Unique Protocol Identification Number

NCT02281097

Brief Title

Transdermal Vagal Stimulation for POTS

Official Title

Transdermal Vagal Stimulation for the Treatment of Postural Tachycardia Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 2013 (Actual)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postural Orthostatic Tachycardia Syndrome

Keywords

Postural Orthostatic Tachycardia Syndrome, POTS, Vagal Stimulation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vagal Stimulation First

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo First

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Stimulation

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Heart Rate (average of 1 minute)

Description

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.

Time Frame

[-5,0,5,10,15,20,..,50 min] relative time from tilt

Secondary Outcome Measure Information:

Title

Orthostatic Symptoms (Subjective analog symptoms scale (0-100)

Description

Subjective analog symptoms scale (0-100)

Time Frame

[-5,0,5,10,15,20,..,50 min] relative time from tilt

Title

Orthostatic Tolerance (Maximal tolerated time in upright position)

Description

Maximal tolerated time in upright position

Time Frame

[0-50 min] relative time from tilt

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Non-smoking patients who qualify with the criteria of idiopathic postural tachycardia syndrome will be studied. The criteria are: an increase of heart rate of 30 beats/minute or an upright heart rate of >= 120 bpm, and 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andre Diedrich, MD, PhD

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Italo Biaggioni, MD

Organizational Affiliation

Vanderbilt University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Autonomic Dysfunction Center, Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232-2195

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No. There is no plan to share data.

Links:

URL

https://www.vumc.org/autonomic-dysfunction-center/vanderbilt-autonomic-dysfunction

Description

Vanderbilt Autonomic Dysfunction Center

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Transdermal Vagal Stimulation for POTS

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