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

Autonomic Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06268288
• Other study ID #: 22-011492
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2024
• Est. completion date: July 2024

Study information

• Verified date: June 2024
• Source: Mayo Clinic
• Contact: Brandi Johnson
• Phone: 507-284-3373
• Email: johnson.brandi1[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Dysfunction
• Autonomic Nervous System Diseases
• Postural Orthostatic Tachycardia Syndrome
• Postural Tachycardia Syndrome
• Primary Dysautonomias
• Syndrome
• Tachycardia

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in COMPASS-31 scores between individuals in both arms of the study	Evaluation of the COMPASS-31 score changes from the start to the finish in individuals in both arms of the study	2 months
Primary	The change in Child Functional Disability Inventory scores between individuals in both arms of the study	Evaluation of the change in Child Functional Disability Inventory scores between individuals in both arms of the study	2 months
Primary	The change in heart rate increase in head up tilt table tests in individuals in both arms of the study	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	2 month interval
Secondary	Does nVNS influence headache frequency in adolescent patients with POTS	Evaluation of patient logs for headache frequency in individual patients in both arms of the study	2 months
Secondary	Does nVNS influence ability to increase exercise duration in adolescent patients with POTS	Evaluation of patient logs for duration of average weekly exercise	2 months
Secondary	Does use of nVNS influence degree of depression in adolescent patients with POTS	Evaluation of PHQ-9 surveys from start to finish of study between the two groups	2 months