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

Not Applicable

Completed

• Conditions: Autonomic Dysfunction; POTS - Postural Orthostatic Tachycardia Syndrome; Postural Tachycardia Syndrome; Postural Orthostatic Tachycardia Syndrome
• Interventions: Other: STEPS management protocol; Device: GammaCore intervention

• Registration Number: NCT06268288
• Lead Sponsor: Mayo Clinic

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.

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.

Study Timeline

• Study First Submitted: 2024-02-13
• Study First Submitted QC: 2024-02-13
• Study Start: 2024-02-14
• Study First Posted: 2024-02-20
• Primary Completion: 2024-10-05
• Study Completion: 2024-10-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS	STEPS management protocol	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.
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)	GammaCore intervention	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.
STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)	STEPS management protocol	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.

Primary Outcome Measures

Name	Time	Method
The change in COMPASS-31 scores between individuals in both arms of the study	2 months	Evaluation of the COMPASS-31 score changes from the start to the finish in individuals in both arms of the study
The change in Child Functional Disability Inventory scores between individuals in both arms of the study	2 months	Evaluation of the change in Child Functional Disability Inventory scores between individuals in both arms of the study
The change in heart rate increase in head up tilt table tests in individuals in both arms of the study	2 month interval	Evaluation of the difference in heart rate increase from initial Head up tilt table test (HUTT) from start of study to end of study in individuals in both arms of the study

Secondary Outcome Measures

Name	Time	Method
Does nVNS influence ability to increase exercise duration in adolescent patients with POTS	2 months	Evaluation of patient logs for duration of average weekly exercise
Does use of nVNS influence degree of depression in adolescent patients with POTS	2 months	Evaluation of PHQ-9 surveys from start to finish of study between the two groups
Does nVNS influence headache frequency in adolescent patients with POTS	2 months	Evaluation of patient logs for headache frequency in individual patients in both arms of the study

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States