NCT06268288

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 12 Years – 19 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-02-14
• Primary completion: 2024-10-05
• Completion: 2024-10-05
• First posted: 2024-02-20
• Last updated: 2025-10-31
• Results posted: 2025-10-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study