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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: Active Phase 1 study of Postural Tachycardia Syndrome, sponsored by Vanderbilt University Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Average of high frequency variability of heart rate during the head up tilt
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-09-30 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What the registry record for NCT03124355 still lists
NCT03124355 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 82-participant average among 19 other Postural Tachycardia Syndrome trials with a reported enrollment target (87% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Postural Tachycardia Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03124355's enrollment target sits among peer trials
11 20th of 19 the lowest of 19 other Postural Tachycardia Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Postural Tachycardia Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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