Cognitive Rehabilitation for Concussion

(CORE Trial)

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

354 Participants Needed

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?

Research shows that cognitive rehabilitation can help improve attention, memory, and other cognitive functions in people with brain injuries like traumatic brain injury (TBI) and stroke. This suggests that similar approaches, like On-TRACC, might also be effective for treating concussions. ^{1 2 3 4 5}

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. ^{4 6 7 8 9}

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. ^{1 3 4 10 11}

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Quality of guidelines for cognitive rehabilitation following traumatic brain injury. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Evidence-based cognitive rehabilitation: recommendations for clinical practice. [2022]

4. England pubmed.ncbi.nlm.nih.gov

EFNS guidelines on cognitive rehabilitation: report of an EFNS task force. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. United States pubmed.ncbi.nlm.nih.gov

Yoga and Mindfulness Intervention for Concussion Recovery. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

De-implementing Prolonged Rest Advice for Concussion in Primary Care Settings: A Pilot Stepped Wedge Cluster Randomized Trial. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Impact of Number of Drugs on Rehabilitation Outcomes in Patients after Traumatic Brain Injury: A Retrospective Cohort Study. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Optimizing the electronic medical record to improve patient care and conduct quality improvement initiatives in a concussion specialty clinic. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation in traumatic brain injury. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation following traumatic brain injury: assessment to treatment. [2009]