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Completed

NCT Number: NCT06268288

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

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.

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Key information

Conditions

Postural Tachycardia Syndrome Autonomic Dysfunction Autonomic Nervous System Diseases Nervous System Diseases Orthostatic Intolerance POTS - Postural Orthostatic Tachycardia Syndrome Postural Orthostatic Tachycardia Syndrome Primary Dysautonomias

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Rochester, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient's age 12-19 years of age
  • Newly diagnosed POTS at Mayo Clinic in Rochester
  • Head up tilt table test results in a heart rate increase of 40 or more bpm
  • Consent is able to be obtained appropriately per age

Exclusion criteria

  • POTS patients with orthostatic hypotension
  • POTS patients with vasovagal syncope
  • Use of medications other than midodrine or metoprolol
  • Inability to independently utilize the GammaCore device
  • Inability to independently complete surveys or patient logs
  • Patients receiving hormonal therapy other than birth control
  • Pregnancy
  • Prior neck surgery
  • Metallic implant present
  • Cardiac disorder
  • Presence of an eating disorder
  • Use of a feeding tube

Treatment and study plan

GammaCore intervention

Device

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 names: external vagal nerve stimulator, non-invasive vagal nerve stimulator

STEPS management protocol

Other

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

Primary outcomes

  1. The Change in Composite Autonomic Symptom Score (COMPASS-31)

    Time frame: Baseline; 8 Weeks

    The change in COMPASS-31 score from baseline to 8 weeks. COMPASS-31 measures autonomic dysfunction in patients with neurodegenerative diseases. It consists of 31 patient-reported questions assessing various symptoms, including orthostatic intolerance, vasomotor symptoms, and gastrointestinal issues. Total scores range from 0 to 100, with higher scores indicating more severe symptoms.

  2. The Change in Child Functional Disability Inventory Scores

    Time frame: Baseline; 8 Weeks

    The change in Child Functional Disability Inventory scores from baseline to eight weeks. The Child Functional Disability Inventory assesses the physical and psychosocial functioning of children due to their physical health. It consists of 15 items that measure activity limitations due to being sick or not feeling well. The total scores range from 0 to 60 with higher scores indicating greater perceived functional disability.

  3. The Change in Heart Rate (Beats Per Minute) in Head up Tilt Table Tests

    Time frame: Baseline; 8 Weeks

    The change in heart rate, measured in beats per minute (BPM), in the head up tilt table test (HUTT) from baseline to 8 weeks.

Secondary outcomes

  1. Change in the Number of Headaches Experienced by Adolescent Patients With POTS

    Time frame: Baseline; 8 Weeks

    The change in the number of headaches from baseline to 8 weeks experienced by adolescent patients with POTS.

  2. Change in Exercise Duration (Minutes) in Adolescent Patients With POTS

    Time frame: Baseline; 8 Weeks

    The change in the exercise duration (minutes) in adolescent patients with POTS from baseline to 8 weeks.

  3. Change in PHQ-9 Scores in Adolescent Patients With POTS

    Time frame: Baseline; 8 Weeks

    The change in the Patient Health Questionnaire 9-item (PHQ-9) scale score from baseline to 8 weeks. PHQ-9 is used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 20, 2024
Registry last updated
Oct 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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