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ACTIVE NOT RECRUITING
NCT03124355
PHASE1

Vagal Stimulation in POTS

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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.

Official title: Vagal Stimulation in POTS - The Autonomic Inflammatory Reflex (Pilot 3)

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

11

Start Date

2017-09-30

Completion Date

2026-12

Last Updated

2025-08-05

Healthy Volunteers

No

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

Locations (1)

Autonomic Dysfunction Center/ Vanderbilt University Medical Center

Nashville, Tennessee, United States