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NCT06859996 · ClinicalTrials.gov registry record · NA
CORE (Cognitive Optimization Through Rehabilitation and Education) Study
A NA study, sponsored by University of Washington.
- Recruiting
- Registry status
- NA
- Development phase
- 354
- Enrollment target
NCT06859996 is a NA study that is actively recruiting participants, run by University of Washington. The registered enrollment target is 354 participants.
The verdict
NCT06859996, a NA study, is actively recruiting participants, sponsored by University of Washington.
- RECRUITING
- Registry status
- NA
- Development phase
- 354 participants
- Enrollment target
Study Summary
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 subs
Interventions
- BEHAVIORAL Tools for Rehabilitation and Cognitive Care (On-TRACC)
- BEHAVIORAL Brain Health psychoeducation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 354 participants |
| Start Date | 2025-10-27 |
| Est. Completion | 2029-09 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06859996
The ClinicalTrials.gov registry entry for NCT06859996 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 354 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Tools for Rehabilitation and Cognitive Care (On-TRACC) is the first listed.
NCT06859996 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06859996 about?
NCT06859996 is a clinical study titled "CORE (Cognitive Optimization Through Rehabilitation and Education) Study". 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. How...
What is the current status of trial NCT06859996?
This trial is currently recruiting. It is a NA study. The enrollment target is 354 participants. The study started on 2025-10-27. Estimated completion is 2029-09.
What interventions are being tested in trial NCT06859996?
The interventions under investigation include: Tools for Rehabilitation and Cognitive Care (On-TRACC) (BEHAVIORAL), Brain Health psychoeducation (BEHAVIORAL).
Who is sponsoring clinical trial NCT06859996?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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