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

Last updated: December 4, 2024
Sponsor: Mayo Clinic
Overall Status: Completed

Phase

N/A

Condition

Heart Disease

Dysrhythmia

Fast Heart Rate (Tachycardia)

Treatment

STEPS management protocol

GammaCore intervention

Clinical Study ID

NCT06268288
22-011492
  • Ages 12-19
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Patient's age 12-19 years of age

  2. Newly diagnosed POTS at Mayo Clinic in Rochester

  3. Head up tilt table test results in a heart rate increase of 40 or more bpm

  4. Consent is able to be obtained appropriately per age

Exclusion

Exclusion criteria:

  1. POTS patients with orthostatic hypotension

  2. POTS patients with vasovagal syncope

  3. Use of medications other than midodrine or metoprolol

  4. Inability to independently utilize the GammaCore device

  5. Inability to independently complete surveys or patient logs

  6. Patients receiving hormonal therapy other than birth control

  7. Pregnancy

  8. Prior neck surgery

  9. Metallic implant present

  10. Cardiac disorder

  11. Presence of an eating disorder

  12. Use of a feeding tube

Study Design

Total Participants: 40
Treatment Group(s): 2
Primary Treatment: STEPS management protocol
Phase:
Study Start date:
February 14, 2024
Estimated Completion Date:
October 05, 2024

Study Description

Project purpose: The investigators will study the use of non invasive vagal nerve stimulation in newly diagnosed adolescent patients with POTS to see if symptom management improves over 2 months. Surveys will include COMPASS-31. Child Functional Disability Inventory, and PHQ-9. Patient logs will evaluate headache frequency, exercise duration and VNS use.

Research objectives: The investigators hypothesize that:

Primary Aim 1. Use of noninvasive vagal nerve stimulation will decrease autonomic symptom intensity compared to control group.

Primary Aim 2. Use of noninvasive vagal nerve stimulator will improve child function.

Primary Aim 3. Heart rate elevation measured by head up tilt table test will decrease in the treatment group compared to the control group.

Secondary goals include:

Secondary Aim 1: To determine if utilization of noninvasive vagal nerve stimulation influences headache frequency Secondary Aim 2: Determine if utilization of noninvasive vagal nerve stimulation will influence weekly duration of aerobic exercise.

Secondary Aim 3: Determine if utilization of noninvasive vagal nerve stimulator results in significant side effects, particularly depression, in adolescent patients.

Connect with a study center

  • Mayo Clinic

    Rochester, Minnesota 55901
    United States

    Site Not Available

  • Mayo Clinic in Rochester

    Rochester, Minnesota 55905
    United States

    Site Not Available

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