Symptom-Targeted Rehabilitation for Concussion (STAR-C)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.