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Vagal Stimulation for POTS

N/A

Waitlist Available

Led By Andre Diedrich, MD, PhD

Research Sponsored by Vanderbilt University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must also be able to safely withdraw from medications that influence heart rate, blood pressure, and hormone levels that regulate blood pressure

Criteria include chronic problems of symptoms during upright posture for at least 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up [-5,0,5,10,15,20,..,50 min] relative time from tilt

Summary

This trial is testing whether electrical stimulation of a nerve through the skin of the ear may help people with high heart rates and symptoms of light-headedness, fatigue, and headache when they stand up.

Who is the study for?

This trial is for adults aged 18-75 with Postural Orthostatic Tachycardia Syndrome (POTS), who experience rapid heartbeat and symptoms like light-headedness when standing. Participants must be able to stop taking certain medications, not smoke, and have had POTS symptoms for at least 6 months. Pregnant individuals or those with major medical conditions like cancer or heart disease cannot join.

What is being tested?

The study is testing if electrical stimulation of a nerve in the ear can help control heart rate and reduce symptoms associated with POTS. Participants will either receive this nerve stimulation or a placebo treatment without any active effects to compare results.

What are the potential side effects?

Potential side effects may include discomfort at the site of stimulation on the ear, skin irritation, headache, or an unexpected increase in heart rate due to the intervention. The full range of side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can safely stop taking my heart rate, blood pressure, and certain hormone medications.

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I have had symptoms when standing up for at least 6 months.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ [-5,0,5,10,15,20,..,50 min] relative time from tilt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~[-5,0,5,10,15,20,..,50 min] relative time from tilt

This trial's timeline: 3 weeks for screening, Varies for treatment, and [-5,0,5,10,15,20,..,50 min] relative time from 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

Heart Rate (average of 1 minute)

Secondary study objectives

Orthostatic Symptoms (Subjective analog symptoms scale (0-100)

Orthostatic Tolerance (Maximal tolerated time in upright position)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Vagal Stimulation FirstActive Control2 Interventions

Vagal stimulation to improve upright heart rate modulation and symptoms is given on first tilt study day. Placebo stimulation with ineffective low amplitude and frequency (sham intervention) is given on second tilt study.

Group II: Placebo FirstPlacebo Group2 Interventions

Placebo stimulation with ineffective low amplitude and frequency (sham intervention) is given on first tilt study day. Vagal stimulation to improve upright heart rate modulation and symptoms is given on second tilt study day.

0 / 3Eligibility criteria met