Back to search results

CORE Study for Mild Traumatic Brain Injury and Concussion

This study, called CORE, is looking at ways to help people who have lasting symptoms after a mild traumatic brain injury (mTBI) or concussion. Many people experience symptoms like problems with thinking or headaches for a long time after their injury. This study is testing two different approaches delivered through telehealth: "Tools for Rehabilitation and Cognitive Care (On-TRACC)" and "Brain Health psychoeducation." Both involve one-on-one sessions with a clinician to discuss health and lifestyle factors that can affect your thinking. Researchers will measure changes in your symptoms using questionnaires before, immediately after, and three months after treatment. You may be able to join if you are over 18 and have a documented mTBI that happened at least three months ago. The study aims to enroll 354 participants.

Study design
This is an interventional study planning to enroll 354 participants. It compares two behavioral interventions delivered one-on-one via telehealth.
What's involved
You would have an introductory session followed by 5 treatment sessions, all delivered one-on-one via telehealth. Your symptoms will be assessed before, immediately after, and three months after treatment.
Compensation
Not stated in the trial record.
Follow-up
Your symptoms will be monitored for three months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06859996

CORE (Cognitive Optimization Through Rehabilitation and Education) Study

Recruiting
NAAges 18+InterventionalTreatment
University of Washington
~354 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:Tools for Rehabilitation and Cognitive Care (On-TRACC)Brain Health psychoeducation

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neurobehavioral Symptom Inventory Total Score
Measured over Pre-treatment, Immediately post-treatment, 3-months post-treatment
+1 more outcome measured

Conditions

Mild Traumatic Brain Injury; Concussion

Explore related trials

Concussion

Where it's being run

2 sites across 1 states
Washington2

Study leadership

  • Kathleen Pagulayan, PhD · PRINCIPAL_INVESTIGATOR · University of Washington
  • Rhonda Williams, PhD · PRINCIPAL_INVESTIGATOR · VA Puget Sound Health Care System

Who to contact

Anna Frauenheim, MPH
[email protected]
(206) 543-7731
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

\>18 years of age
Evidence of self-reported mTBI sustained in adulthood at least 3 months prior to the date of study enrollment (clinical discretion allowed for mTBI in late adolescence) AND documentation of diagnosed or suspected mTBI as defined by American Congress of Rehabilitation Medicine (ACRM) criteria in the medical record (e.g., on the problem list, has a diagnosis, encounter for a TBI, diagnosis via a TBI evaluation, or documented in a clinical note, etc).
Endorsement of at least moderate symptoms (score of 3 or higher) on at least one of the cognitive items (forgetfulness, poor concentration, taking longer to think) from the Rivermead Postconcussion Symptom Questionnaire.
Ability to read, speak and understand English enough to participate in healthcare in English without a translator.
Willingness to participate in audio-recorded treatment sessions.
Willingness to be randomized to treatment condition.
Willingness to use clinical video teleconferencing (CVT) for research appointments (including be on camera for treatment sessions).
Able to use and have access to a smart phone, tablet, or computer with internet access in private setting for treatment sessions.
Willingness to refrain from participation in any other clinical trial or interventional study while participating in this study

Exclusion

History of neurologic injury or illness other than mTBI that can affect cognitive functioning (e.g., any lifetime severe TBI \[Glasgow Coma Score (GCS)\<=8; loss of consciousness (LOC)\> 1 hour; posttraumatic amnesia (PTA)\>1 week\], seizure disorder, multiple sclerosis, neurodegenerative disorder). Any definitively diagnosed moderate TBI is exclusionary, but injuries that are in the mild to moderate range are eligible pending clinical discretion. If available records and/or self-reported information do not allow for a definitive determination of whether an injury is mild or moderate, then clinician discretion will be used to determine eligibility.
Active suicidal ideation/intent indicating significant risk, per PI discretion.
Unstable medical or psychiatric condition (e.g., mania, psychotic symptoms) that would interfere with study participation, per PI discretion.
Behavioral issues noted in the record or observed during the screening process that would interfere with appropriate or safe CVT participation or study procedures, per PI discretion.
Prior participation in the On-TRACC intervention.
Significant cognitive impairment that would limit ability to engage in treatment (as indicated by more than 1 error on a 6-item screener).
Planned life events that would interfere with study participation during active treatment phase (e.g., major surgery, moving out of state, extended travel).
Current participation in another clinical trial or interventional study.

What this trial measures

  • Neurobehavioral Symptom Inventory Total ScorePre-treatment, Immediately post-treatment, 3-months post-treatment

    Measure of post-concussive symptoms. Minimum value=0; maximum value=88; higher scores indicate worse outcomes.

  • Neurobehavioral Symptom Inventory Cognitive Subscale ScorePre-treatment, Immediately post-treatment, 3-months post-treatment

    Cognitive post-concussive symptoms. Minimum value=0; maximum value=16; higher scores indicate worse outcomes.