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N/A Completed N=40 Randomized Single-blind Treatment

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
Source: ClinicalTrials.gov NCT06268288 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcomePrimary: The Change in Composite Autonomic Symptom Score (COMPASS-31) — -5.40; -5.94 score on a scale

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.

Outcome Measures

OutcomeResultp-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 —

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
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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