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ACTIVE NOT RECRUITING Phase 1

Vagal Stimulation in POTS

NCT03124355 · View on ClinicalTrials.gov ↗

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.

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03124355

The ClinicalTrials.gov registry entry for NCT03124355 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 695 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03124355 reports 1 study location spanning 1 distinct geographic area — top geographies include Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03124355?

This trial is sponsored by Vanderbilt University Medical Center, which has 695 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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