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

NCT06268288 | Completed Results FDA Device

• 1 other identifier: 22-011492
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (3)

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

  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.

  Baseline; 8 Weeks

• The Change in Child Functional Disability Inventory Scores

  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.

  Baseline; 8 Weeks

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

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

  Baseline; 8 Weeks

Secondary Outcomes (3)

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

  Baseline; 8 Weeks

• Change in Exercise Duration (Minutes) in Adolescent Patients With POTS

  Baseline; 8 Weeks

• Change in PHQ-9 Scores in Adolescent Patients With POTS

  Baseline; 8 Weeks

Study Arms (2)

Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS

ACTIVE COMPARATOR

The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilize a specific management program for their patients with Postural Orthostatic Tachycardia Syndrome utilizing the acronym STEPS. S is for liberal intake of salt, T is for drinking 90-100 ounces/day of fluid, E is for slowly and gradually improve continuous aerobic exercise duration to a goal of 50 minute most days of the week, P is for possible utilization of 1 of two prescription medications (metoprolol or midodrine), and S is for setting priorities and goals such as encouraging good sleep hygiene, attendance at school, social interactions, and counseling.

Other: STEPS management protocol

STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)

EXPERIMENTAL

Utilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day.

Device: GammaCore intervention; Other: STEPS management protocol

Interventions

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

Also known as: external vagal nerve stimulator, non-invasive vagal nerve stimulator

STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)

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

STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation); Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55901, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Autonomic Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Lytitia Shea, M.D.
• Organization: Mayo Clinic

shea.lytitia@mayo.edu

507-422-9847

Study Officials

• Lytitia Shea, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Half of the patient population will be randomized to standard management only. The other half of the population will be randomized to standard management plus use of the vagal nerve stimulator

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 20, 2024
• Study Start: February 14, 2024
• Primary Completion: October 5, 2024
• Study Completion: October 5, 2024
• Last Updated: October 31, 2025
• Results First Posted: October 31, 2025

Record last verified: 2025-10

Locations

US (2)