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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: Recruiting NA study, sponsored by University of Washington.
NCT06859996 is a NA study that is actively recruiting participants, run by University of Washington. The registered enrollment target is 354 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Measure of post-concussive symptoms. Minimum value=0; maximum value=88; higher scores indicate worse outcomes.
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 |
What NCT06859996 shows while recruiting
NCT06859996 is an interventional study that assigns participants to a tested intervention. The registered 354 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (75% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06859996's enrollment target sits among peer trials
354 291st of 2000 higher than 1,709 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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