N/A
N=40
Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)
Postural Tachycardia Syndrome · Autonomic Dysfunction · Postural Orthostatic Tachycardia Syndrome · POTS - Postural Orthostatic Tachycardia Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT06268288 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: The Change in Composite Autonomic Symptom Score (COMPASS-31) — -5.40; -5.94 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GammaCore intervention (Device); STEPS management protocol (Other)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Composite Autonomic Symptom Score (COMPASS-31) |
-5.40; -5.94 | — |
| PRIMARY The Change in Child Functional Disability Inventory Scores |
-2.92; -3.40 | — |
| PRIMARY The Change in Heart Rate (Beats Per Minute) in Head up Tilt Table Tests |
47.50; 58.14; 42.50; 40.14 | — |
| SECONDARY Change in the Number of Headaches Experienced by Adolescent Patients With POTS |
1.00; 1.30; 1.20; 0.40 | — |
| SECONDARY Change in Exercise Duration (Minutes) in Adolescent Patients With POTS |
25.00; 21.40; 32.50; 17.90 | — |
| SECONDARY Change in PHQ-9 Scores in Adolescent Patients With POTS |
0.23; -3.39 | — |
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.
Eligibility Criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Pregnancy
- Prior neck surgery
- Metallic implant present
- Cardiac disorder
- Presence of an eating disorder
- Use of a feeding tube
Data sourced from ClinicalTrials.gov (NCT06268288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.