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New treatment option for Mild Traumatic Brain Injury; Concussion
Official title CORE (Cognitive Optimization Through Rehabilitation and Education) Study
ClinicalTrials.gov ID: NCT06859996
What this study is testing
- What it's testing
- Mild traumatic brain injury (mTBI) affects millions of individuals worldwide every year. It has long been thought that the vast majority of individuals who sustain a mTBI experience natural recovery with little or no intervention and return to baseline functioning within days to weeks of injury.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- \>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...
- Endorsement of at least moderate symptoms (score of 3 or higher) on at least one of the cognitive items (forgetfulness, poor concentration, taking...
- 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.
You likely can't join if
- History of neurologic injury or illness other than mTBI that can affect cognitive functioning (e.g., any lifetime severe TBI [Glasgow Coma Score...
- Alcohol abuse (operationalized as scoring 15 or more if male or 13 or more if female on the Alcohol Use Disorders Identification Test), or high-risk...
- 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...
- Prior participation in the On-TRACC intervention.
See the full eligibility criteria
- \>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...
- 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 assigned by chance 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 treatment study while participating in this study
- History of neurologic injury or illness other than mTBI that can affect cognitive functioning (e.g., any lifetime severe TBI [Glasgow Coma Score (GCS)\ 1 hour; posttraumatic amnesia (PTA)\>1 week], seizure disorder...
- Alcohol abuse (operationalized as scoring 15 or more if male or 13 or more if female on the Alcohol Use Disorders Identification Test), or high-risk illicit drug use (as defined by modified Tobacco, Alcohol...
- 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 treatment study.
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.