Cognitive Rehabilitation for Concussion

(CORE Trial)

Not yet recruiting at 1 trial location

Overseen By Anna C Frauenheim, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Severe TBI, Alcohol abuse, Drug use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with ongoing symptoms after a mild concussion. It aims to reduce issues such as forgetfulness, poor concentration, and slow thinking through a program called Tools for Rehabilitation and Cognitive Care (On-TRACC), compared to basic brain health education. Participants will engage in six online sessions and may benefit if they experienced a mild concussion at least three months ago and still face noticeable cognitive issues. As an unphased trial, this study provides a unique opportunity to potentially enhance cognitive health with innovative rehabilitation techniques.

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 prior data suggests that the On-TRACC intervention is safe for individuals with mTBI?

Research has shown that cognitive rehabilitation programs like On-TRACC are generally well-tolerated by people with mild-to-moderate traumatic brain injury (TBI). Studies have found that this type of therapy improves attention, memory, and other thinking skills without causing significant side effects. Although specific data on side effects for On-TRACC is not available, cognitive rehabilitation is considered safe and is often recommended for TBI patients to enhance their thinking abilities. Since this trial does not involve testing a new drug or device, it focuses on therapy sessions, which are less likely to cause physical side effects. Participants can expect to improve their cognitive skills through structured exercises and strategies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about On-TRACC because it offers a fresh approach to cognitive rehabilitation for concussions. Unlike traditional treatments that often rely on rest and gradual return to activities, On-TRACC uses innovative cognitive care tools that aim to directly enhance brain health and function. This method could potentially speed up recovery and improve cognitive outcomes by actively engaging patients in targeted brain exercises, making it a promising alternative to current standard care options.

What evidence suggests that On-TRACC might be an effective treatment for persistent post-concussive symptoms?

Research has shown that digital brain exercises can help individuals with traumatic brain injuries (TBI) think more clearly. Studies have found that these exercises can enhance attention, memory, and the speed of information processing, which are often affected by mild traumatic brain injuries (mTBI). In this trial, participants may receive On-TRACC, the treatment under focus, designed to help manage these cognitive issues. While specific data on On-TRACC is still being gathered, the success of similar digital tools for TBI suggests it could be beneficial. This method aims to reduce symptoms after a concussion and improve overall quality of life. ^{1 2 4 6 7}

Who Is on the Research Team?

Kathleen Pagulayan, PhD

Principal Investigator

University of Washington

Rhonda Williams, PhD

Principal Investigator

VA Puget Sound Health Care System

Are You a Good Fit for This Trial?

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

Ability to read, speak and understand English enough to participate in healthcare in English without a translator

I am willing to be assigned to a treatment by chance.

I am willing to have my treatment sessions audio-recorded.

Exclusion Criteria

Prior participation in the On-TRACC intervention

Alcohol abuse or high-risk illicit drug use in the past 3 months

Active suicidal ideation/intent indicating significant risk

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete 6 treatment sessions via telehealth, either On-TRACC or psychoeducation

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3-months post-treatment

3 months

2 visits (virtual)

Optional Booster Sessions

Participants may attend weekly booster sessions between 3 and 6-months post-treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Tools for Rehabilitation and Cognitive Care (On-TRACC)

Trial Overview This trial tests On-TRACC, a cognitive rehabilitation tool, against brain health psychoeducation to see which better reduces post-concussive symptoms. It includes assessments and follow-ups at 3 months, with exploratory aims extending to 6 months after treatment.

How Is the Trial Designed?

Group I: On-TRACC Experimental Treatment 1 Intervention

Group II: Brain Health Psychoeducation Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Trials

83

Recruited

10,500+

VA Puget Sound Health Care System

Collaborator

Trials

67

Recruited

225,000+

Published Research Related to This Trial

A multidisciplinary approach to rehabilitation, involving a team that supports physical, cognitive, and social skills, is crucial for positive outcomes after traumatic brain injury (TBI).

Methylphenidate is well-supported as an effective medication for improving attention and memory in individuals with significant impairments following TBI, while cholinesterase inhibitors may not be beneficial and could worsen behavioral issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation in traumatic brain injury. Cernich, AN., Kurtz, SM., Mordecai, KL., et al.[2021]

A pilot study involving 21 family physicians showed that training on new return-to-activity guidelines after concussion significantly increased physicians' knowledge (from 6.3 to 8.8 correct answers out of 10) and adherence to the guidelines (from 25% to 86%).

Despite the positive changes in knowledge and adherence, the study faced challenges in recruitment and retention, indicating that improvements are needed for a larger trial to effectively implement these guidelines in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

De-implementing Prolonged Rest Advice for Concussion in Primary Care Settings: A Pilot Stepped Wedge Cluster Randomized Trial. Silverberg, ND., Otamendi, T., Panenka, WJ., et al.[2023]

A systematic review of 112 studies on cognitive rehabilitation for traumatic brain injury (TBI) and stroke found strong evidence supporting interventions for attention, memory, social communication skills, and executive function, indicating effective treatment options for cognitive disabilities.

The review also highlighted the effectiveness of specific interventions for visuospatial rehabilitation after right hemisphere stroke and for addressing aphasia and apraxia after left hemisphere stroke, providing a solid foundation for evidence-based rehabilitation protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Cicerone, KD., Langenbahn, DM., Braden, C., et al.[2022]

Cognitive rehabilitation is a structured intervention that helps individuals recover cognitive skills after a brain injury, using tailored treatment plans based on thorough neuropsychological assessments.

It has been shown to be effective for a range of cognitive impairments, from mild to severe injuries, and can lead to significant improvements in cognitive abilities and overall psychosocial functioning at any time after the injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation following traumatic brain injury: assessment to treatment. Tsaousides, T., Gordon, WA.[2009]

The largest randomized controlled trial on rehabilitation after traumatic brain injury (TBI) shows that both cognitive and functional rehabilitation methods are effective, providing empirical support for their use in recovery.

Each type of intervention (cognitive and functional) has distinct advantages for specific subpopulations of TBI patients, highlighting the need for tailored rehabilitation approaches in occupational therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive versus functional approaches to rehabilitation after traumatic brain injury: commentary on a randomized controlled trial. Giles, GM.[2019]

Citations

1. withpower.com withpower.com/trial/phase-mild-traumatic-brain-injury-concussion-3-2025-951f1

Cognitive Rehabilitation for Concussion (CORE Trial) Trial Overview This trial tests On-TRACC, a cognitive rehabilitation tool, against brain health psychoeducation to see which better reduces post-concussive ...

2. ichgcp.net ichgcp.net/clinical-trials-registry/NCT06859996

Tools for Rehabilitation and Cognitive Care (On-TRACC) and ... AIM 2: Compare the efficacy of On-TRACC and psychoeducation on change in secondary outcomes, including cognitive self-efficacy, compensatory ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12537419/

The effectiveness of digital cognitive intervention in patients ... This meta-analysis supports the efficacy of digital cognitive intervention in improving cognitive function in TBI patients. We recommend ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S000399931931305X

Management of Concussion and Mild Traumatic Brain Injury The article offers guidance on key clinical decisions in mTBI care and highlights priority interventions that can be initiated in primary care to prevent ...

5. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1608645/full

A comprehensive review of rehabilitation approaches for ... This comprehensive review critically examines key rehabilitation strategies for TBI, including neuropsychological assessments, cognitive and neuroplasticity- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12202449/

A comprehensive review of rehabilitation approaches for ... Cognitive rehabilitation helps individuals with mild-to-moderate traumatic brain injury (TBI) manage problems with attention, memory, and ...

7. neurology.org neurology.org/doi/10.1212/WNL.0000000000200041

Cognitive Outcome 1 Year After Mild Traumatic Brain Injury Poor 1-year cognitive outcome is common, affecting 13.5% of patients with mTBI vs 4.5% of controls. These results highlight the need for better understanding ...