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Not Yet Recruiting
NCT07872761
Mindful RAVANS Study
Conditions: mTBI - Mild Traumatic Brain Injury, Posttraumatic Stress Disorder, Posttraumatic Headache
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Spaulding Rehabilitation Hospital
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Inclusion: Adults (18+) with mTBI + current PTHA symptoms (≥4/10 pain) meeting ICHD-3 criterion 5.2.251, with HIT-6 ≥56
Exclusion Criteria:
* Severe substance use disorder
* skin conditions or metal in left ear impacting stimulation.
Source: ClinicalTrials.gov (NCT07872761). StuddyBuddy aggregates publicly available trial information.