An interventional study of Cala-RAVANS (Model CR-2) and Sham in mTBI - Mild Traumatic Brain Injury, Posttraumatic Stress Disorder and Posttraumatic Headache, sponsored by Spaulding Rehabilitation Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Spaulding Rehabilitation Hospital · Not applicable, Interventional, and Treatment
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.
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.
550 studies on the registry are indexed under Brain Concussion; 154 are open to participants now.
This study's planned enrollment of 20 is below the median of 64 across 376 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →Spaulding Rehabilitation Hospital is the lead sponsor of 117 studies on the registry; 27 are open to participants now.
Of its 20 completed or terminated interventional studies of FDA-regulated products, 17 (85%) have results posted.
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Exclusion Criteria:
Mindful-RAVANS (pairing 30 mins of mindfulness of breathing meditation + Respiratory-gated Auricular Vagal Afferent Nerve Stimulation (RAVANS)
Device: Cala-RAVANS (Model CR-2)
Sham transcutaneous vagus nerve stimulation (tVNS) + Sham Meditation
Other: Sham
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.
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.
Recruitment Rate
Recruitment will be assessed as the number of participants screened, eligible, and enrolled in the study. Unit of Measure: Participants
Time frame: Day 0 through Day 56
Retention
Retention will be assessed as the percentage of randomized participants who complete study follow-up. A retention rate of 70% or greater is the prespecified feasibility benchmark. Unit of Measure: Percent of participants
Time frame: Day 0 through Day 56
Adherence
Adherence will be assessed based on completion of the four planned in-person intervention sessions within the intended 2-week intervention period. An adherence rate of 70% or greater is the prespecified feasibility benchmark. Unit of Measure: Percent of intervention sessions completed
Time frame: Day 0 through Day 56
Outcome Data Completeness
Outcome data completeness will be assessed as the completeness of study outcome data collected across the planned study assessments. Unit of Measure: Percent
Time frame: Day 0 through Day 56
Feasibility of Intervention Measure
Perceived feasibility of the intervention will be assessed using the 4-item Feasibility of Intervention Measure (FIM). Each item is rated on a 1-to-5 response scale, with higher scores indicating greater perceived feasibility. Unit of Measure: Units on a scale
Time frame: Day 0 through Day 56
Frequency of Adverse Events
Number of adverse events reported during the study, including events such as ear discomfort or skin reactions at the electrode site, headache, dizziness or lightheadedness, nausea, psychological distress, and device malfunction. Adverse events are recorded throughout the study and reviewed by study clinicians. Unit of Measure: Adverse events
Time frame: Session 1 through Day 56
Severity of Adverse Events
Severity of each reported adverse event will be graded by a study clinician as mild (no interference with usual activity), moderate (some interference with usual activity), or severe (prevents usual activity).
Time frame: Session 1 through Day 56
Relatedness of Adverse Events to Study Procedures
Each reported adverse event will be assessed by a study clinician for its relationship to study procedures as unrelated, possibly related, probably related, or definitely related.
Time frame: Session 1 through Day 56
Acceptability of Intervention Measure (AIM)
Acceptability will be assessed using the 4-item Acceptability of Intervention Measure (AIM). Participants rate four statements about their approval of and satisfaction with Mindful RAVANS on a 5-point scale ranging from completely disagree to completely agree. Higher scores indicate greater perceived acceptability of the intervention. Unit of Measure: Units on a scale
Time frame: Day 14
Intervention Appropriateness Measure (IAM)
Perceived appropriateness will be assessed using the 4-item Intervention Appropriateness Measure (IAM). Participants rate four statements about how fitting, suitable, applicable, and well-matched Mindful RAVANS is on a 5-point scale ranging from completely disagree to completely agree. Higher scores indicate greater perceived appropriateness of the intervention. Unit of Measure: Units on a scale
Time frame: Day 14
Client Satisfaction Questionnaire (CSQ-8)
Participant satisfaction will be assessed using the 8-item Client Satisfaction Questionnaire (CSQ-8), which asks about aspects of the services received, including quality, whether participants received the type of service they wanted, whether their needs were met, willingness to recommend the service, amount of help received, perceived helpfulness, overall satisfaction, and willingness to use the service again. Higher scores indicate greater satisfaction. Unit of Measure: Units on a scale
Time frame: Day 14
Change in headache impact
Measured with the 6-item Headache Impact Test (HIT-6), which assesses how much headaches interfere with daily life; scores range from 36 to 78, with higher scores meaning greater impact. Unit of Measure: Units on a scale
Time frame: Day 0 to Day 28
Change in Post-Concussive Symptoms
Measured with the 22-item Post-Concussion Symptom Scale (PCSS), which assesses the severity of post-concussive symptoms over the past 2 days. Each symptom is rated from 0 (none) to 6 (severe), yielding a total score ranging from 0 to 132, with higher scores indicating greater overall post-concussive symptom severity. Unit of Measure: Units on a scale
Time frame: Day 0 to Day 14
Change in post-traumatic stress symptoms
Measured with the weekly version of the 20-item PTSD Checklist for DSM-5 (PCL-5); scores range from 0 to 80, with higher scores meaning more severe symptoms. Unit of Measure: Units on a scale
Time frame: Day 0 to Day 14
Change in state anxiety
Measured with a 0-100 visual analog scale for anxiety (VAS-Anxiety) completed immediately before and after each 30-minute intervention session. Participants rate how anxious they feel at that moment, from 0 (not at all anxious) to 100 (extremely anxious), with higher scores indicating greater state anxiety. Unit of Measure: Units on a scale
Time frame: Pre- and post-session, Sessions 1-4
Change in state pain
Measured with a 0-100 visual analog scale for pain (VAS-Pain) completed immediately before and after each 30-minute intervention session. Participants rate how much head pain they have at that moment, from 0 (no pain) to 100 (worst pain imaginable), with higher scores indicating greater state pain. Unit of Measure: Units on a scale
Time frame: Pre- and post-session, Sessions 1-4
Change in state brain fog
Measured with a single 0-100 visual analog scale for brain fog (VAS-Brain Fog), adapted from item 12 of the Fatigue and Altered Cognition Scale (FACs), and completed immediately before and after each 30-minute intervention session. Participants rate how clear or foggy their thinking feels at that moment, from 0 (not at all foggy/clear) to 100 (completely foggy), with higher scores indicating greater brain fog. Unit of Measure: Units on a scale
Time frame: Pre- and post-session, Sessions 1-4
Change in Pain Severity
Measured with the Brief Pain Inventory (BPI) Pain Severity Score, calculated as the mean of four 0-10 ratings of pain at its worst, at its least, on average, and right now. Higher scores indicate greater pain severity. Unit of Measure: Units on a scale
Time frame: Day 0 to Day 14
Change in Pain Interference
Measured with the Brief Pain Inventory (BPI) Pain Interference Score, calculated as the mean of seven 0-10 ratings assessing how much pain interferes with general activity, mood, walking ability, normal work, relationships with other people, sleep, and enjoyment of life. Higher scores indicate greater pain interference. Unit of Measure: Units on a scale
Time frame: Day 0 to Day 14
Change in pain catastrophizing
Measured with the 13-item Pain Catastrophizing Scale (PCS), which assesses negative thinking about pain; scores range from 0 to 52, with higher scores meaning more catastrophizing.
Time frame: Day 0 to Day 56
Change in fatigue and cognitive impairment
Measured with the Fatigue and Altered Cognition Scale (FACs), which assesses fatigue and "brain fog"; higher scores mean greater difficulty.
Time frame: Day 0 to Day 56
Change in mindfulness
Measured with the 15-item Mindful Attention Awareness Scale (MAAS), which assesses everyday present-moment attention, scored as a 1-6 mean; higher scores mean greater mindfulness.
Time frame: Day 0 to Day 28
Change in interoceptive awareness
Measured with the 37-item Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2), which assesses awareness of bodily sensations across 8 subscales scored 0-5; higher scores mean greater awareness.
Time frame: Day 0 to Day 28
Change in emotion regulation
Measured with the 16-item Difficulties in Emotion Regulation Scale (DERS-16); scores range from 16 to 80, with higher scores meaning more difficulty regulating emotions.
Time frame: Day 0 to Day 28
Change in quality of life
Measured with the 6-item Quality of Life after Brain Injury Overall Scale (QOLIBRI-OS), scored 0-100; higher scores mean better quality of life.
Time frame: Day 0 to Day 56
Change in Anxiety
Measured with the anxiety domain of the PROMIS-29, which assesses anxiety symptoms during the past 7 days. Scores are reported as standardized T-scores, with higher scores indicating greater anxiety. Unit of Measure: T-score
Time frame: Day 0 to Day 56
Change in Depression
Measured with the depression domain of the PROMIS-29, which assesses depressive symptoms during the past 7 days. Scores are reported as standardized T-scores, with higher scores indicating greater depressive symptoms. Unit of Measure: T-score
Time frame: Day 0 to Day 56
Change in Pain Interference
Measured with the pain interference domain of the PROMIS-29, which assesses how much pain interfered with day-to-day activities, work around the home, social activities, and household chores during the past 7 days. Scores are reported as standardized T-scores, with higher scores indicating greater pain interference. Unit of Measure: T-score
Time frame: Day 0 to Day 56
Change in Fatigue
Measured with the fatigue domain of the PROMIS-29, which assesses fatigue and its impact during the past 7 days. Scores are reported as standardized T-scores, with higher scores indicating greater fatigue. Unit of Measure: T-score
Time frame: Day 0 to Day 56
Change in Sleep Disturbance
Measured with the sleep disturbance domain of the PROMIS-29, which assesses sleep quality and sleep-related problems during the past 7 days. Scores are reported as standardized T-scores, with higher scores indicating greater sleep disturbance. Unit of Measure: T-score
Time frame: Day 0 to Day 56
Change in Pain Intensity
Measured with the single PROMIS-29 pain intensity item, which asks participants to rate their average pain on a scale from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Unit of Measure: Units on a scale
Time frame: Day 0 to Day 56
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.
Of 222 non-industry interventional studies with no phase under Brain Concussion, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's planned 4 months is below that.
Counting every sponsor, half of 236 studies reached it within 28 months; a quarter within 19 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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