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New cognitive rehab program aims to clear mental fog after mild brain injury

NCT ID NCT06859996

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a structured cognitive rehabilitation program (On-TRACC) helps adults with lasting memory, attention, and thinking problems after a mild traumatic brain injury or concussion. Participants will receive six telehealth sessions of either On-TRACC or a general brain-health education program. The goal is to see which approach better reduces cognitive symptoms and improves quality of life over several months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
behavioral intervention (cognitive rehabilitation vs. psychoeducation)
What this could lead to
If On-TRACC proves better than basic education, it could become a standard, brief therapy for persistent cognitive problems after mild TBI.
What could go wrong
This is a mid-sized trial comparing two talk-based programs, not a drug or device. The difference between them may be small, and results may not apply to all types of brain injury.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 354 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 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 Criteria: * 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. * 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, Prescription Medications and Substance Use/Misuse (TAPS) Tool subscale scores \> 2) in the past 3 months. Indication of alcohol/drug abuse or dependence in medical record is also sufficient to meet this exclusion criteria, per PI discretion. * 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.

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Conditions

The condition(s) this trial relates to.

Brain Concussion traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • VA Puget Sound Health Care System

    RECRUITING

    Seattle, Washington, 98108, United States

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