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Vagal Nerve Stimulation for POTS

Phase 1
Waitlist Available
Led By Italo Biaggioni, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female subjects of 18-45 years, with Postural Tachycardia Syndrome (POTS) as defined by a heart rate increase ≥30 bpm from supine within 10 min of standing or head-up tilt in the absence of orthostatic hypotension, with chronic symptoms (> 6 months), and in the absence of other acute cause of orthostatic tachycardia.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 min of head up tilt
Awards & highlights

Study Summary

This trial is investigating the effects of electrical nerve stimulation on the involuntary nervous system's control of heart rate and symptoms in female patients with POTS. The study will last 5 days and screen 16 patients, 13 of which will be eligible to participate in the study days.

Who is the study for?
This trial is for women aged 18-45 with Postural Tachycardia Syndrome (POTS), experiencing a rapid heartbeat upon standing. Participants must have had POTS symptoms for over 6 months and be able to consent. Excluded are those pregnant, with conditions explaining POTS, bed/chair-ridden individuals, or anyone on medications affecting autonomic function who can't stop them before the study.Check my eligibility
What is being tested?
The study tests electrical stimulation of a nerve in the earlobe and its effects combined with galantamine or pyridostigmine pills compared to placebo in controlling heart rhythm and reducing symptoms when standing in POTS patients. It involves screening plus three testing days over five days total.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, reactions to medication like digestive issues or headaches, and possible changes in heart rate or blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 18-45 with POTS, experiencing a rapid heart rate increase when standing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 min of head up tilt
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 min of head up tilt for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
High frequency variability of heart rate

Trial Design

3Treatment groups
Experimental Treatment
Group I: Pyridostigmine with vagal/sham stimulationExperimental Treatment3 Interventions
Patients will receive a single oral dose of pyridostigmine pill 30 mg, and 1.5-2 hours later they will have two tilt table tests: one with vagal stimulation and one with sham vagal stimulation
Group II: Placebo pill with vagal/sham stimulationExperimental Treatment3 Interventions
Patients will receive a single oral dose of placebo sugar pill, and 1.5-2 hours later they will have two tilt table tests: one with vagal stimulation and one with sham vagal stimulation
Group III: Galantamine with vagal/sham stimulationExperimental Treatment3 Interventions
Patients will receive a single oral dose of galantamine pill 8 mg, and 1.5-2 hours later they will have two tilt table tests:one with vagal stimulation and one with sham vagal stimulation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
placebo sugar pill
2006
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,181 Total Patients Enrolled
16 Trials studying Postural Orthostatic Tachycardia Syndrome
898 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Italo Biaggioni, MDPrincipal InvestigatorVanderbilt University Medical Center
28 Previous Clinical Trials
1,443 Total Patients Enrolled
4 Trials studying Postural Orthostatic Tachycardia Syndrome
213 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome

Media Library

Vagal Stimulation Clinical Trial Eligibility Overview. Trial Name: NCT03124355 — Phase 1
Postural Orthostatic Tachycardia Syndrome Research Study Groups: Placebo pill with vagal/sham stimulation, Pyridostigmine with vagal/sham stimulation, Galantamine with vagal/sham stimulation
Postural Orthostatic Tachycardia Syndrome Clinical Trial 2023: Vagal Stimulation Highlights & Side Effects. Trial Name: NCT03124355 — Phase 1
Vagal Stimulation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03124355 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must a person fulfill in order to be eligible for this clinical research?

"This trial is seeking 11 female volunteers aged 18-45 who suffer from Postural Tachycardia Syndrome (POTS). Criteria for enrolment include chronic (>6 months) symptoms of POTS, as defined by an elevated heart rate of at least 30 bpm within 10 minutes of standing or tilting without orthostatic hypotension. Additionally, there must be no other active causes contributing to the tachycardia."

Answered by AI

How many participants have been enrolled in this clinical investigation?

"At present, this trial is not looking for participants. It was originally posted on September 30th 2017 and last edited October 27th 2022. However, if you are still searching for a study to join, there are currently 120 trials recruiting those with marijuana abuse issues and 6 involving Vagal stimulation that need volunteers."

Answered by AI

Is the elderly population eligible to participate in this research experiment?

"This trial is seeking participants aged 18-45."

Answered by AI

What medical issues can be addressed with Vagal stimulation?

"Typically, vagal stimulation is employed to help patients suffering from myasthenia gravis. However, it has also proven successful in treating dyschezia, orthostatic syncope, and non-depolarizing neuromuscular blocking agents."

Answered by AI

Are there still openings within this clinical investigation?

"According to data on clinicaltrials.gov, this research is no longer recruiting patients; the trial was initially posted in September 2017 and most recently updated in October 2022. Nevertheless, there are currently 126 other trials that require participants."

Answered by AI

What adverse effects are associated with Vagal nerve stimulation?

"Limited clinical data exists regarding the safety of vagal stimulation, so it has been assigned a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Vagal Stimulation in POTS
Italo Biaggioni 2017. "Vagal Stimulation in POTS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03124355.
~0 spots leftby Jun 2024
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