Postural Tachycardia SyndromeNCT06268288
Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)
A study testing GammaCore intervention and STEPS management protocol in people with Postural Tachycardia Syndrome and Autonomic Dysfunction, run by Mayo Clinic at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Tachycardia Syndrome, Autonomic Dysfunction, Postural Orthostatic Tachycardia Syndrome
- What is being tested?
- GammaCore intervention and STEPS management protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Feb 2024to 5 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patient's age 12-19 years of age
- Newly diagnosed POTS at Mayo Clinic in Rochester
- Head up tilt table test results in a heart rate increase of 40 or more bpm
- Consent is able to be obtained appropriately per age
Who cannot join
- POTS patients with orthostatic hypotension
- POTS patients with vasovagal syncope
- Use of medications other than midodrine or metoprolol
- Inability to independently utilize the GammaCore device
- Inability to independently complete surveys or patient logs
- Patients receiving hormonal therapy other than birth control
Show all 12Show fewer
- Pregnancy
- Prior neck surgery
- Metallic implant present
- Cardiac disorder
- Presence of an eating disorder
- Use of a feeding tube
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55901
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Pilot Study--The Effects of Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)
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.
Read the 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.
- Conditions
- Postural Tachycardia Syndrome, Autonomic Dysfunction, Postural Orthostatic Tachycardia Syndrome, POTS - Postural Orthostatic Tachycardia Syndrome
- Being tested
- GammaCore intervention, STEPS management protocol
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome, Primary Dysautonomias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GammaCore interventionDevice
Also called external vagal nerve stimulator, non-invasive vagal nerve stimulator
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 protocolOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: STEPS management protocol |
| 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. Receives: Device: GammaCore intervention; Other: STEPS management protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline; 8 Weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline; 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start14 Feb 2024
- Primary completion5 Oct 2024
- Study completion5 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postural Tachycardia SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lytitia M. Shea, Mayo Clinic
- Investigators
- Lytitia Shea, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268288
- Sponsor's protocol ID
- 22-011492
- Status last verified
- Oct 2025
- First submitted
- 13 Feb 2024
- Last updated
- 31 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study--The Effects of Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)
- ClinicalTrials.gov ID
- NCT06268288
- Acronym / sponsor ID
- 22-011492
- Conditions
- Postural Tachycardia Syndrome, Autonomic Dysfunction, Postural Orthostatic Tachycardia Syndrome, POTS - Postural Orthostatic Tachycardia Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 5 Oct 2024 (actual)
- Study completion
- 5 Oct 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Posted 31 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS | Active comparator | Other: STEPS management protocolThe 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 | Device: GammaCore intervention, Other: STEPS management protocolUtilization of STEPS management goals plus the addition of non invasive vagal nerve stimulators for two 2 minutes of intervention performed three times a day. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patient's age 12-19 years of age
- Newly diagnosed POTS at Mayo Clinic in Rochester
- Head up tilt table test results in a heart rate increase of 40 or more bpm
- Consent is able to be obtained appropriately per age
Key exclusion criteria (12 listed)
- POTS patients with orthostatic hypotension
- POTS patients with vasovagal syncope
- Use of medications other than midodrine or metoprolol
- Inability to independently utilize the GammaCore device
- Inability to independently complete surveys or patient logs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GammaCore interventionAlso: external vagal nerve stimulator, non-invasive vagal nerve stimulatorUse of the vagal nerve stimulator, GammaCore, on the right side of the neck for two 2 minute stimulations performed 3 times a day | Device | STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation) |
| STEPS management protocolSTEPS 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 | Other | STEPS + GammaCore Intervention (noninvasive vagal nerve stimulation), Standard Postural Orthostatic Tachycardia Syndrome management/ STEPS |
Primary outcome
The Change in Composite Autonomic Symptom Score (COMPASS-31)
Time frame: Baseline; 8 Weeks
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.
The Change in Child Functional Disability Inventory Scores
Time frame: Baseline; 8 Weeks
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.
The Change in Heart Rate (Beats Per Minute) in Head up Tilt Table Tests
Time frame: Baseline; 8 Weeks
The change in heart rate, measured in beats per minute (BPM), in the head up tilt table test (HUTT) from baseline to 8 weeks.
3 secondary outcomes
Change in the Number of Headaches Experienced by Adolescent Patients With POTS
Time frame: Baseline; 8 Weeks
Change in Exercise Duration (Minutes) in Adolescent Patients With POTS
Time frame: Baseline; 8 Weeks
Change in PHQ-9 Scores in Adolescent Patients With POTS
Time frame: Baseline; 8 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lytitia Shea, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GammaCore intervention and STEPS management protocol in people with Postural Tachycardia Syndrome and Autonomic Dysfunction, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Change in Composite Autonomic Symptom Score (COMPASS-31) (time frame: Baseline; 8 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2025.