CompletedNot Applicable

Non-invasive Vagal Neurostimulation (nVNS) in Adolescents With Postural Orthostatic Tachycardia Syndrome (POTS)

United States40 participantsStarted 2024-02-14

Plain-language 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.

Who can participate

Age range12 Years – 19 Years

SexALL

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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

What they're measuring

The Change in Composite Autonomic Symptom Score (COMPASS-31)

Timeframe: Baseline; 8 Weeks

The Change in Child Functional Disability Inventory Scores

Timeframe: Baseline; 8 Weeks

The Change in Heart Rate (Beats Per Minute) in Head up Tilt Table Tests

Timeframe: Baseline; 8 Weeks

Trial details

NCT IDNCT06268288

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-05

Results submitted2025-10-03

View on ClinicalTrials.gov More Postural Tachycardia Syndrome trials