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Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)

NCT06268288 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-10-31

Study results available
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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.

Conditions

  • Postural Tachycardia Syndrome
  • Autonomic Dysfunction
  • Postural Orthostatic Tachycardia Syndrome
  • POTS - Postural Orthostatic Tachycardia Syndrome

Interventions

DEVICE

GammaCore intervention

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

OTHER

STEPS management protocol

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

Sponsors & Collaborators

Principal Investigators

  • Lytitia Shea, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-14
Primary Completion
2024-10-05
Completion
2024-10-05
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06268288 on ClinicalTrials.gov