CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
GammaCore intervention +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06268288
NCT06268288N/ACompleted
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Pilot Study--The Effects of Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)

Mayo Clinic·interventional·Posted Feb 20, 2024·Updated Oct 31, 2025

In Brief

A clinical study evaluating GammaCore intervention and STEPS management protocol for Postural Tachycardia Syndrome and 3 related conditions. Completed, enrolled 40 participants across 2 sites.

Detailed Summary

The purpose of this study is to determine if nVNS will decrease autonomic symptom intensity (COMPASS-31 and Child Functional Disability Inventory) in adolescent patients with postural orthostatic tachycardia syndrome (POTS) in comparison to standard recovery STEPS management.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPostural Tachycardia Syndrome, Autonomic Dysfunction, Postural Orthostatic Tachycardia Syndrome, POTS - Postural Orthostatic Tachycardia Syndrome
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedFeb 20, 2024
Enrollment StartFeb 14, 2024
Primary CompletionOct 5, 2024
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 2.4 years ago

Interventions

GammaCore interventiondevice

Use of the vagal nerve stimulator, GammaCore, on the right side of the neck for two 2 minute stimulations performed 3 times a day

STEPS management protocolother

STEPS is the acronym for the standard management program for our patients with POTS. It includes liberal use of salt, taking in 90-100 ounces of fluid, gradually increasing the duration of aerobic exercise, possible use of one of two prescription medications (metoprolol, and midodrine), and encouragement to set priority and goals