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Mindful RAVANS Study
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.
Official title: Mindful Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS) for Mild Traumatic Brain Injury
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-11-01
Completion Date
2027-03-01
Last Updated
2026-10-14
Healthy Volunteers
No
Interventions
Cala-RAVANS (Model CR-2)
The intervention, called Mindful RAVANS, combines a 30-minute guided mindfulness-of-breathing meditation with gentle electrical stimulation of the vagus nerve, delivered through a small electrode placed in the left ear. A belt around the chest tracks the person's breathing so the stimulation turns on only when they breathe out, which earlier research suggests strengthens its calming effect on the body's stress response. The stimulation is set to a comfortable, below-pain level for each person, and participants complete four of these sessions in person over two weeks.
Sham
In the sham (placebo) version, participants wear the same ear electrode and breathing belt, but the device delivers no electrical stimulation. Instead of the mindfulness meditation, they listen to a "sham meditation" recording of the same length, designed to resemble meditation without teaching real mindfulness techniques. To keep people from guessing their group, everyone is told they may or may not feel stimulation, and in past studies many people in the sham group reported feeling something even though the device was off.