Seattle, WANCT06859996Now EnrollingIRB Ready

Mild Traumatic Brain Injury; Concussion Clinical Trial in Seattle, WA

Access cutting-edge mild traumatic brain injury; concussion treatment through this clinical trial at a research site in Seattle. Study-provided care at no cost to qualified participants.

Sponsored by University of Washington

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Expert Care in Seattle

Access mild traumatic brain injury; concussion specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related mild traumatic brain injury; concussion treatment provided free

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Check if you qualify for this mild traumatic brain injury; concussion clinical trial in Seattle, WA

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Why Participate?

  • No-Cost Study Care

  • Local to Seattle

    Convenient for WA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Seattle site if eligible
  4. 4Begin participation

About This Mild Traumatic Brain Injury; Concussion Study in Seattle

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. However, recent large studies have demonstrated that a substantial number of individuals experience prolonged symptoms (e.g., cognitive impairment, headaches, affective symptoms). These symptoms, termed "Persistent Post-concussive Symptoms" (PPCS) are associated with significant functional disability and reduced quality of life (QOL) and can last for years post-injury. While PPCS can include affective, cognitive, and somatosensory/vestibular symptoms, objective and subjective cognitive symptoms - particularly in the domains of attention, memory, processing speed, and executive function - are among the most commonly reported following mTBI. There is currently no gold-standard intervention to address these symptoms. To address this gap, our research group developed a brief cognitive rehabilitation intervention called Tools for Rehabilitation and Cognitive Care (or On-TRACC). The goals of this clinical trial are: AIM 1: Compare the efficacy of On-TRACC to a psychoeducation control on reduction of self-reported cognitive post-concussive symptoms (Aim 1.1) and overall neurobehavioral post concussive symptoms and (Aim 1.2) following treatment and at 3-month follow-up (Aim 1.3) in a randomized clinical trial of community-dwelling adults with mTBI. AIM 2: Compare the efficacy of On-TRACC and psychoeducation on change in secondary outcomes, including cognitive self-efficacy, compensatory strategy use, self-management skills, and quality of life at post-treatment and 3-month follow-up. Exploratory AIM 3: Compare the efficacy of On-TRACC and psychoeducation on: primary and secondary outcomes at 6-months post-treatment and (Aim 3.1) explore whether engaging in On-TRACC leads to subsequent engagement in care by assessing whether there is a different level of participation in optional intervention booster sessions in the post-intervention period (Aim 3.2). All participants will: * Complete a series of assessments * Complete 6 treatment sessions via telehealth (either On-TRACC or psychoeducation) All participants will have the option of: * Attending weekly "Booster Sessions" between 3 and 6-months post-treatment * Completing neuropsychological assessments at 2 timepoints during the study

Sponsor: University of Washington

Who Can Participate

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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Seattle?

Yes, this clinical trial (NCT06859996) has an active research site in Seattle, WA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Mild Traumatic Brain Injury; Concussion Treatment Options in Seattle, WA

If you're searching for mild traumatic brain injury; concussion treatment options in Seattle, WA, this clinical trial (NCT06859996) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Seattle research site is actively enrolling participants for this clinical trial. You'll receive care from experienced mild traumatic brain injury; concussion specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all mild traumatic brain injury; concussion clinical trials near you to find additional studies recruiting in your area.

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