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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

Must not have

Subjects taking any medication known to affect autonomic function or inflammatory markers (e.g. corticosteroids) who could not discontinue them before study participation

Patients who are bedridden or chair-ridden

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 15 min of head up tilt

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.

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.

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

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I am a woman aged 18-45 with POTS, experiencing a rapid heart rate increase when standing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot stop taking medication that affects my body's automatic processes or inflammation for the study.

Select...

I am unable to get out of bed or a chair by myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 15 min of head up tilt

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

0 / 3Eligibility criteria met