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Vagal Stimulation in POTS

NCT03124355 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-08-05

No results posted yet for this 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

  • Postural Tachycardia Syndrome

Interventions

DRUG

placebo sugar pill

placebo single oral dose

DRUG

Pyridostigmine Pill

pyridostigmine bromide 30 mg single oral dose

DRUG

Galantamine Pill

Galantamine hydrobromide 8mg single oral dose

DEVICE

Vagal stimulation

Vagal stimulation will be given at 50 Hz during the tilt table tests

DEVICE

Sham vagal stimulation

Sham vagal stimulation will be given at 0.01 mA during the tilt table tests

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Italo Biaggioni, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03124355 on ClinicalTrials.gov