Clinical trial NCT06268288: Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)
Official title: Pilot Study--The Effects of Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Tachycardia Syndrome
Autonomic Dysfunction
Postural Orthostatic Tachycardia Syndrome
POTS - Postural Orthostatic Tachycardia Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change in COMPASS-31 scores between individuals in both arms of the study
timeFrame: 2 months
measure: The change in Child Functional Disability Inventory scores between individuals in both arms of the study
timeFrame: 2 months
measure: The change in heart rate increase in head up tilt table tests in individuals in both arms of the study
timeFrame: 2 month interval
Secondary outcomes:
measure: Does nVNS influence headache frequency in adolescent patients with POTS
timeFrame: 2 months
measure: Does nVNS influence ability to increase exercise duration in adolescent patients with POTS
timeFrame: 2 months
measure: Does use of nVNS influence degree of depression in adolescent patients with POTS
timeFrame: 2 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Lytitia Shea, MD
role: PRINCIPAL_INVESTIGATOR
References: