Cure8 trial brief
The trial evaluated an investigational, non-drug vagal nerve stimulation device as a potential therapy for ulcerative colitis in adolescents and young adults, which could expand treatment options beyond conventional medications if later proven effective and safe.
Patients with ulcerative colitis (including adolescents), caregivers, IBD clinicians, and researchers interested in neuromodulation or device-based therapies.
This is a completed single-center, randomized, sham-controlled, double-blinded 12-week interventional study of a Respiratory-Gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) device in people with ulcerative colitis.
Participants (planned N=30) were randomized 2:1 to active stimulation or sham and performed two home therapy sessions per day, with clinic visits at baseline and week 12 and a telehealth check at week 6. The study's primary outcome was clinical remission at 12 weeks measured by a modification of the UCDAI (remission defined as a 0 or 1 point score).
Eligibility included ages 10–39, UC for ≥3 months, UCDAI 3–6, fecal calprotectin ≥150 µg/g, and requirements for stable background medications (including specific windows for immunomodulators, biologics, JAK and S1P modulators).
This brief is grounded in the ClinicalTrials.gov registry entry. The record describes study design and planned outcomes but does not include results; therefore no efficacy or safety conclusions can be drawn from this entry alone.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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