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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS | Active Comparator | 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) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GammaCore intervention | Device | Use of the vagal nerve stimulator, GammaCore, on the right side of the neck for two 2 minute stimulations performed 3 times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline; 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline; 8 Weeks |
| Change in Exercise Duration (Minutes) in Adolescent Patients With POTS |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lytitia Shea, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55901 | United States | ||
| Mayo Clinic in Rochester |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS | The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilized 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 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 9, 2023 |
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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
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| STEPS management protocol | Other | 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 |
|
The change in the exercise duration (minutes) in adolescent patients with POTS from baseline to 8 weeks. |
| Baseline; 8 Weeks |
| 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. | Baseline; 8 Weeks |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| FG001 | STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation) | 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. 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 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 |
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Postural Orthostatic Tachycardia Syndrome Management/ STEPS | The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilized 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 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 |
| BG001 | STEPS + GammaCore Intervention (Noninvasive Vagal Nerve Stimulation) | 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. 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 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of participants was limited to 12 years through 18 years of age | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Stratified randomization was used to ensure an equal number of males in the two arms of the studies. This was done to balance the few males expected in the study compared to females. Diagnoses of POTS in adolescents occurs primarily in females. | Count of Participants | Participants |
| |||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 8 Weeks |
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| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline; 8 Weeks |
| |||||||||||||||||||||||||||||||
| Primary | 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. | Everyone had a baseline head up tilt table test. The repeat tilt table test was voluntary and resulted in fewer patients participating in this repeat test. The reason we made this voluntary is that many participants live far away and return for a repeat head up tilt table is inconvenient and costly. | Posted | Mean | Standard Deviation | Beats per Minute (BPM) | Baseline; 8 Weeks |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | One patient in the standard POTS management/STEPS arm and two patients in the STEPS + GammaCore arm did not fill out the patient log at week 8 that documented the number of headaches they experienced. Due to this, no data exists for week 8 for these patients. | Posted | Median | Full Range | Headaches | Baseline; 8 Weeks |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | One patient in the standard POTS management/STEPS arm and two patients in the STEPS + GammaCore arm did not fill out the patient log at week 8 that documented exercise duration in minutes. Due to this, no data exists for week 8 for these patients. | Posted | Median | Full Range | Minutes | Baseline; 8 Weeks |
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| Secondary | 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. | Seven patients in the Device group and seven patients in the Control group had incomplete data for the PHQ-9 scores (missing either the baseline PHQ-9 survey or the final PHQ-8 at 8 weeks). | Posted | Mean | Standard Deviation | score on a scale | Baseline; 8 Weeks |
|
Adverse events were collected from the time of informed consent through study completion, approximately 8 weeks.
Adverse events were collected through patient logs and questionnaires.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS | The General Pediatric and Adolescent Medicine providers at Mayo Clinic utilized 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 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 | 0 | 20 | 0 | 20 | 4 | 20 |
| EG001 | STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation) | 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. 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 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 | 0 | 20 | 0 | 20 | 9 | 20 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Increase Headaches | Nervous system disorders | Systematic Assessment |
| ||
| Increased Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Bloating/Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
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| Increased Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Loose Stool | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mood Swings | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lytitia Shea, M.D. | Mayo Clinic | 507-422-9847 | shea.lytitia@mayo.edu |
| Oct 3, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D054972 | Postural Orthostatic Tachycardia Syndrome |
| D054969 | Primary Dysautonomias |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation) |
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. 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 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 |
|
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| OG001 | STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation) | 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. 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 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 |
|
|
| STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation) |
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. 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 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 |
|
|
| STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation) |
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. 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 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 |
|
|
| OG001 | STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation) | 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. 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 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 |
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