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NCT03124355 · ClinicalTrials.gov registry record · Phase 1

Vagal Stimulation in POTS

A Phase 1 study of Postural Tachycardia Syndrome, sponsored by Vanderbilt University Medical Center.

Active
Registry status
Phase 1
Development phase
11
Enrollment target
1
Study location

NCT03124355 is a Phase 1 study of Postural Tachycardia Syndrome that is active but no longer recruiting, run by Vanderbilt University Medical Center. The registered enrollment target is 11 participants, below the 82-participant average among 19 other Postural Tachycardia Syndrome trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03124355, a Phase 1 study of Postural Tachycardia Syndrome, is active but no longer recruiting, sponsored by Vanderbilt University Medical Center.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
11 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to investigate how the electrical stimulation of a nerve in the skin of the earlobe (transcutaneous vagal nerve stimulation), alone or in combination with two medications (galantamine and pyridostigmine), affects the way the autonomic (involuntary) nervous system controls heart rhythm, symptoms on standing, and inflammatory markers in female patients with postural tachycardia syndrome (POTS). The study consists of 2 parts: a screening (1-2 study days), and 3 testing days. The study will take 5 days total and about 16 participants will be screened for the study. The investigators estimate 13 will be eligible to participate in all of the study days.

Conditions Studied

Postural Tachycardia Syndrome

Interventions

  • DEVICE Vagal stimulation
  • DRUG placebo sugar pill
  • DRUG Pyridostigmine Pill
  • DRUG Galantamine Pill
  • DEVICE Sham vagal stimulation

Study Locations (1)

Tennessee

  • Autonomic Dysfunction Center/ Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2017-09-30
Est. Completion 2026-12
Phase Phase 1

Sponsor

Vanderbilt University Medical Center

677 total trials

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What the Registry Record Tells You About NCT03124355

The ClinicalTrials.gov registry entry for NCT03124355 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 82-participant average among 19 other Postural Tachycardia Syndrome trials with a reported enrollment target (87% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Postural Tachycardia Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Vagal stimulation is the first listed.

NCT03124355 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT03124355 about?

NCT03124355 is a clinical study titled "Vagal Stimulation in POTS". The purpose of this study is to investigate how the electrical stimulation of a nerve in the skin of the earlobe (transcutaneous vagal nerve stimulation), alone or in combination with two medications (galantamine and pyridostigmine), affects the way the autonomic (involuntary) nervous system control...

What is the current status of trial NCT03124355?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2017-09-30. Estimated completion is 2026-12.

What conditions does trial NCT03124355 study?

This clinical trial studies the following conditions: Postural Tachycardia Syndrome.

What interventions are being tested in trial NCT03124355?

The interventions under investigation include: Vagal stimulation (DEVICE), placebo sugar pill (DRUG), Pyridostigmine Pill (DRUG), Galantamine Pill (DRUG), Sham vagal stimulation (DEVICE).

Who is sponsoring clinical trial NCT03124355?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03124355 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.