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

Mayo Clinic

Status: Completed

Conditions: POTS - Postural Orthostatic Tachycardia Syndrome; Postural Orthostatic Tachycardia Syndrome; Postural Tachycardia Syndrome; Autonomic Dysfunction

Treatments: Other: STEPS management protocol; Device: GammaCore intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06268288

22-011492

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 12 to 19 years old

Volunteers: Accepts Healthy Volunteers

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS

Active Comparator group

Description:

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.

Treatment:

Other: STEPS management protocol

STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation)

Experimental group

Description:

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.

Treatment:

Device: GammaCore intervention

Other: STEPS management protocol