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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Use of the vagal nerve stimulator, GammaCore, on the right side of the neck for two 2 minute stimulations performed 3 times a day
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
Mayo Clinic
Rochester, Minnesota, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
The Change in Composite Autonomic Symptom Score (COMPASS-31)
The change in COMPASS-31 score from baseline to 8 weeks. COMPASS-31 measures autonomic dysfunction in patients with neurodegenerative diseases. It consists of 31 patient-reported questions assessing various symptoms, including orthostatic intolerance, vasomotor symptoms, and gastrointestinal issues. Total scores range from 0 to 100, with higher scores indicating more severe symptoms.
Time frame: Baseline; 8 Weeks
The Change in Child Functional Disability Inventory Scores
The change in Child Functional Disability Inventory scores from baseline to eight weeks. The Child Functional Disability Inventory assesses the physical and psychosocial functioning of children due to their physical health. It consists of 15 items that measure activity limitations due to being sick or not feeling well. The total scores range from 0 to 60 with higher scores indicating greater perceived functional disability.
Time frame: Baseline; 8 Weeks
The Change in Heart Rate (Beats Per Minute) in Head up Tilt Table Tests
The change in heart rate, measured in beats per minute (BPM), in the head up tilt table test (HUTT) from baseline to 8 weeks.
Time frame: Baseline; 8 Weeks
Change in the Number of Headaches Experienced by Adolescent Patients With POTS
The change in the number of headaches from baseline to 8 weeks experienced by adolescent patients with POTS.
Time frame: Baseline; 8 Weeks
Change in Exercise Duration (Minutes) in Adolescent Patients With POTS
The change in the exercise duration (minutes) in adolescent patients with POTS from baseline to 8 weeks.
Time frame: Baseline; 8 Weeks
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Change in PHQ-9 Scores in Adolescent Patients With POTS
The change in the Patient Health Questionnaire 9-item (PHQ-9) scale score from baseline to 8 weeks. PHQ-9 is used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression.
Time frame: Baseline; 8 Weeks