Cognitive Rehabilitation for Concussion
(CORE Trial)
Trial Summary
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Tools for Rehabilitation and Cognitive Care (On-TRACC) for concussion?
Is cognitive rehabilitation for concussion safe for humans?
The MYTAC protocol, a mindfulness and yoga intervention for concussion, showed fair tolerability in a small pilot study, with most participants completing the protocol without significant issues, although one participant withdrew due to worsening symptoms. This suggests that cognitive rehabilitation approaches like MYTAC may generally be safe, but larger studies are needed to confirm this.46789
How is the On-TRACC treatment for concussion different from other treatments?
The On-TRACC treatment for concussion is unique because it focuses on cognitive rehabilitation, which involves retraining cognitive skills and teaching compensatory strategies to improve attention, memory, and executive function. This approach is holistic and often involves a multidisciplinary team to support the individual's reintegration into daily life, unlike standard treatments that may not address cognitive aspects as comprehensively.1341011
What is the purpose of this trial?
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
Research Team
Kathleen Pagulayan, PhD
Principal Investigator
University of Washington
Rhonda Williams, PhD
Principal Investigator
VA Puget Sound Health Care System
Eligibility Criteria
The CORE Study is for adults who have had a mild traumatic brain injury (mTBI) and are experiencing lasting symptoms like trouble with memory, attention, or headaches. Participants should be able to attend telehealth sessions and may also join optional 'Booster Sessions' post-treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants complete 6 treatment sessions via telehealth, either On-TRACC or psychoeducation
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 3-months post-treatment
Optional Booster Sessions
Participants may attend weekly booster sessions between 3 and 6-months post-treatment
Treatment Details
Interventions
- Tools for Rehabilitation and Cognitive Care (On-TRACC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborator
VA Puget Sound Health Care System
Collaborator