Symptom-Targeted Rehabilitation for Concussion (STAR-C)
Symptom-Targeted Approach to Rehabilitation for Concussion (STAR-C): RCT of In-person vs Telehealth vs Wait List Control
This project will test whether in-person and telehealth STAR‑C help adults with past concussions reduce everyday cognitive complaints.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 222 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | Henry M. Jackson Foundation for the Advancement of Military Medicine Academic / other |
| Locations | 2 sites (Wahiawa, Hawaii and 1 other locations) |
| Trial ID | NCT06855186 on ClinicalTrials.gov |
What this trial studies
This three-arm randomized controlled trial compares in-person STAR‑C, telehealth STAR‑C, and a wait-list control in adults with persistent mild traumatic brain injury (mTBI) across two military treatment facilities. Participants must have an mTBI sustained more than three months earlier and cognitive complaints on the NSI, and will be randomized to receive symptom-targeted cognitive rehabilitation in person, via telehealth, or no immediate treatment. Primary and secondary outcomes include everyday cognitive complaints (C4) and goal attainment scaling (GAS) measured immediately post-intervention and at one- and three-month follow-ups, with exploratory analyses of factors linked to heterogeneous response. Stakeholder input from clinicians, administrators, and patients will be collected to develop an implementation package for broader clinical use.
Who should consider this trial
Good fit: Adults with a history of mild traumatic brain injury at least three months prior who report cognitive complaints on the NSI and can read at or above a sixth-grade level are the intended participants.
Not a fit: Patients with a history of moderate, severe, or penetrating TBI, lifetime psychotic disorders, or those currently in intensive behavioral health or concurrent cognitive treatments are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, STAR‑C could reduce everyday cognitive complaints and help people with persistent post-concussion symptoms function better in daily life.
How similar studies have performed: Symptom-targeted cognitive rehabilitation approaches have shown mixed but generally promising results for persistent mTBI, while direct evidence for STAR‑C delivered via telehealth is limited and more novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * mTBI defined per the VA/DoD Clinical Practice Guideline for the Management of Concussion-Mild Traumatic Brain Injury sustained in any context (deployment related or non-deployment-related) and at any time longer than 3 months previously. * a score of 2, 3, or 4 on any of the four Cognitive items on the NSI, to include participants who have cognitive complaints. * a score on the Word Reading Subtest of the Wide Range Achievement Test of a sixth-grade reading level or higher, to ensure participants can read study materials. Exclusion Criteria: * History of a moderate, severe, or penetrating TBI as defined by DoD/VA guidelines. * Lifetime diagnosis of schizophrenia or other psychotic/thought disorder. * Current participation in intensive behavioral health treatment (≥3 appointments /encounters per week) for any psychiatric or substance use disorder. * Current participation in other treatments that target cognition within the last two weeks (i.e., healthcare provider-prescribed cognitive rehabilitation in a group or individual format of any time duration or involving digital/game-based format of more than 4 hours per week). * History of a neurological disease affecting cognitive function, other than mild TBI, such as multiple sclerosis, stroke, brain tumor, or Parkinson Disease. * Current, active suicidal or homicidal ideation. * Daily use of narcotic pain medications. * Lack of access to technology or internet/cell phone service that supports telemedicine. * Current participation in other therapy targeting cognition (Note: This is not the same as Cognitive Behavioral Therapy/CBT which addresses psychological issues and may continue during participation in this research project).
Where this trial is running
Wahiawa, Hawaii and 1 other locations
- Desmond T. Doss Health Clinic — Wahiawa, Hawaii, United States (Recruiting)
- Brooke Army Medical Center — San Antonio, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Marc Blaylock
- Email: marc.j.blaylock.ctr@health.mil
- Phone: 210-916-8693
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.