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Mindful RAVANS Study

Study acronym: RAVANS
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
This pilot study is testing a new treatment for people who still have frequent headaches months after a mild traumatic brain injury, with about half of the participants coming from military or veteran backgrounds. The treatment, called "Mindful RAVANS," pairs a guided breathing meditation with gentle electrical stimulation delivered through a small clip in the left ear, timed so the stimulation pulses each time the person breathes out. The idea is that stimulating the vagus nerve, which helps calm the body's stress response, while practicing mindfulness may ease headaches, stress, and other lingering concussion symptoms. Participants are randomly assigned so that three out of four get the real treatment and one out of four gets a look-alike "fake" version, and everyone attends four 30-minute sessions over two weeks, followed by online surveys at two, four, and eight weeks. Because it's an early-stage study, the main goal isn't to prove the treatment works but to find out whether people can stick with it, find it comfortable, and like it enough to justify a larger trial.
Trial Details
NCT Number NCT07872761
Lead Sponsor Spaulding Rehabilitation Hospital
Conditions
(from sponsor)
mTBI - Mild Traumatic Brain Injury, Posttraumatic Stress Disorder, Posttraumatic Headache
Related terms Brain Concussion, Post-Traumatic Headache, Stress Disorders, Post-Traumatic
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov