Mindful RAVANS Study

This feasibility pilot study will randomize 20 patients with mTBI and PTHA 3:1 to 4 sessions of either: (Arm 1) Mindful-RAVANS (pairing 30 mins of mindfulness of breathing meditation + exhalatory RAVANS) vs. (Arm 2) Sham tVNS + Sham Meditation, stratifying based on PTS symptoms (PCL-5) to ensure balanced randomization for PTSD. Participants will be recruited from military-related clinics (i.e., Home Base), Spaulding Rehab, and MGB patient registries. Inclusion: Adults (18+) with mTBI + current PTHA symptoms (≥4/10 pain) meeting ICHD-3 criterion 5.2.251, with HIT-6 ≥56. Exclusion: Severe substance use disorder, skin conditions or metal in left ear impacting stimulation. Study Design: Interested patients will complete a REDCap screening form then phone screen. We will schedule eligible candidates for a Consent/Baseline visit at either Home Base or SRH to complete consent, Day 0 REDCap baseline data collection, and a device orientation session with a coordinator. Then, we will conduct 4 in-person intervention sessions (30-minute recording during stimulation) within 2 weeks measuring anxiety/pain changes immediately before and after intervention, followed by 3 remote data collection sessions with REDCap survey data collected at Day 14, Day 28 and Day 56. Primary Outcomes: Feasibility (FIM), Acceptability (AIM, IAM, CSQ-8), Tolerability (AE). Secondary Outcomes: We will measure change in headache impact from Day 0 to Day 28, change in pain (Visual Analog Pain scale), post-concussive (PCSS), and post-traumatic stress (PCL-5) symptoms from Day 0 to Day 14. We will measure changes in state anxiety (VAS-Anx57), pain (VAS-Pain), and brain fog (VAS-Brain Fog) before and after 30-minute intervention sessions. Exploratory Outcomes: As exploratory outcomes, we will collect during REDCap survey sessions PROMIS-29 (anxiety/depression/pain interference/pain/fatigue/sleep), pain catastrophizing (PCS), Fatigue and Cognitive Impairment (FACs), mindfulness (MAAS), interoceptive awareness (MAIA-2), emotion regulation (DERS-16) and Quality of Life (QoLIBRI-OS)4. Finally, we will conduct exit interviews with 10-12 participants in the Mindful-RAVANS Arm.