Cognitive Rehabilitation for Traumatic Brain Injury

(CRbTBI Trial)

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Penetrating head injury, Neurological, Psychotic, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well a structured rehab program can improve thinking skills and life quality for people with mild brain injuries caused by blasts. Participants will engage in either a cognitive intervention (also known as cognitive training, cognitive therapy, or cognitive remediation), which enhances brain functions, or an educational program that provides helpful information. Active-duty personnel or Veterans from recent military operations who have experienced a blast and had mild brain injuries with brief loss of consciousness might be suitable candidates. The study aims to find effective ways to aid these individuals in their recovery. As an unphased trial, it offers a unique opportunity to contribute to understanding and improving recovery methods for mild brain injuries.

Will I have to stop taking my current medications?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that treatments aimed at improving thinking skills hold promise for people with traumatic brain injury (TBI). Research indicates these treatments can enhance memory and attention without causing serious side effects, and most participants tolerate them well.

Educational programs that teach about TBI and its effects are also considered safe. Studies suggest these programs increase understanding and coping skills, typically without causing negative side effects.

Overall, past research has well-received both the thinking skills treatments and educational programs in this study, suggesting they are safe options for people with traumatic brain injuries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cognitive and educational interventions being studied for traumatic brain injury (TBI) because they offer novel approaches to rehabilitation. Unlike traditional care, which often focuses on medication and physical therapy, these interventions target cognitive processes directly, aiming to enhance memory, attention, and problem-solving skills. The cognitive intervention uses structured mental exercises to stimulate brain function, potentially leading to improvements in daily life activities. Meanwhile, the educational intervention provides patients and their families with critical information about TBI, empowering them to better manage symptoms and challenges. These approaches could complement existing treatments, offering a more comprehensive recovery plan for those affected by TBI.

What evidence suggests that this trial's treatments could be effective for traumatic brain injury?

This trial will compare two approaches for cognitive rehabilitation in individuals with traumatic brain injury (TBI). Participants in one arm will receive a Cognitive Intervention, which research has shown can improve thinking skills, particularly in areas like memory and attention. Digital activities, specifically, have enhanced skills such as problem-solving and planning. Meanwhile, participants in the other arm will receive an Educational Intervention. Previous studies suggest that educational programs, which focus on teaching about TBI, have not significantly affected symptoms or quality of life for TBI patients. ^{2 3 6 7 8}

Who Is on the Research Team?

Yelena Bogdanova, PhD PhD

Principal Investigator

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Are You a Good Fit for This Trial?

This trial is for active-duty personnel or Veterans aged 21-50 who served in OEF/OIF and have mild traumatic brain injury from a blast with loss of consciousness under 30 minutes. It's not for those with penetrating head injuries, previous neurological diagnoses, psychotic disorders before the blast, or significant hearing/vision problems.

Inclusion Criteria

I have lost consciousness for 30 minutes or less.

Military personnel or veterans who were exposed to explosions during Operation Enduring Freedom (OEF) or Operation Iraqi Freedom (OIF).

I am between 21 and 50 years old.

Exclusion Criteria

I have had a penetrating injury to my head.

I have a hearing or vision problem.

I have a history of neurological conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cognitive rehabilitation or educational intervention for cognitive and daily functioning improvement

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Intervention
• Educational intervention

Trial Overview

The study tests how well a structured cognitive rehabilitation program can improve thinking skills and life quality in people with brain injuries caused by blasts. Participants will receive either cognitive interventions or educational sessions to aid their recovery.

How Is the Trial Designed?

Group I: Arm 1 Experimental Treatment 1 Intervention

Cognitive intervention

Group II: Arm 2 Active Control 1 Intervention

Educational intervention

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

Traumatic brain injury (TBI) affects around 1.6 million people in India each year, leading to significant cognitive deficits that require effective rehabilitation strategies.

A multidisciplinary approach to cognitive rehabilitation, including attention training, memory strategies, and problem-solving techniques, is essential for addressing the diverse cognitive impairments experienced by TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Impairment and Rehabilitation Strategies After Traumatic Brain Injury. Barman, A., Chatterjee, A., Bhide, R.[2022]

Traumatic head injuries are increasingly recognized as a significant public health issue, requiring more comprehensive rehabilitation services beyond typical acute care.

Cognitive retraining programs for students with traumatic head injuries aim to enhance independent functioning by improving cognitive skills, social and emotional adjustments, and transitional living experiences, with positive outcomes measured through standardized testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an educationally-based cognitive retraining programme for traumatically head-injured as measured by LNNB pre- and post-test scores. Harrington, DE., Levandowski, DH.[2019]

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]

Cognitive rehabilitation interventions are effective treatments for individuals with traumatic brain injury (TBI), helping to improve cognitive functions, emotional well-being, and overall daily functioning.

These interventions not only enhance awareness of injury-related deficits but also promote community involvement and reduce the risk of secondary disabilities, highlighting their comprehensive role in recovery after TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role and impact of cognitive rehabilitation. Dams-O'Connor, K., Gordon, WA.[2022]

A systematic review of nine studies, including four randomized clinical trials, found that virtual reality (VR) training can significantly improve cognitive functions such as memory and executive function in patients with traumatic brain injury (TBI).

The effective VR treatment protocol involved 10-12 sessions lasting 20-40 minutes each, conducted 2-4 times per week, although the evidence for improvements in attention was weaker.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation post traumatic brain injury: A systematic review for emerging use of virtual reality technology. Alashram, AR., Annino, G., Padua, E., et al.[2019]

Cognitive deficits can lead to significant safety risks, including medication errors and accidents, especially in rehabilitation patients.

Integrating recommendations from various healthcare disciplines and providing education and counseling are crucial strategies to prevent adverse outcomes in patients with cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety considerations in the rehabilitation of the individual with cognitive impairment. Tyson, BT., Pham, MT., Brown, NT., et al.[2012]

In a study of 34 patients with cognitive dysfunction after traumatic brain injury (TBI), those who underwent 30 sessions of computerized cognitive rehabilitation showed significant improvements, particularly younger patients who excelled in various cognitive tests compared to older patients.

The results suggest that age influences the effectiveness of computerized cognitive rehabilitation, with younger individuals benefiting more in areas like verbal memory and attention, while older patients showed limited improvement, indicating a need for further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of computerized cognitive rehabilitation in comparison between young and old age after traumatic brain injury. Kim, SH., Gwak, DW., Jeong, JG., et al.[2023]

A one-month attention remediation program for four young adult males with post-concussion syndrome led to significant improvements in focused, sustained, and divided attention, as well as a marked reduction in symptom intensity for three of the four patients.

The study suggests that attention remediation can be a cost-effective and simple method to enhance psychological and psychosocial functioning in individuals with head injuries, although not all cognitive deficits showed improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remediation of attention deficits in head injury. Nag, S., Rao, SL.[2009]

In a study of 11 soldiers recovering from traumatic brain injuries, those who underwent an average of 80 hours of ThinkRx cognitive rehabilitation training showed significant improvements in cognitive skills, including long-term memory and processing speed.

The results indicated very large effect sizes for the gains in cognitive abilities, suggesting that clinician-delivered cognitive training, especially when combined with digital exercises, can effectively address cognitive deficits following brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Effects of ThinkRx Cognitive Rehabilitation Training for Eleven Soldiers with Brain Injury: A Retrospective Chart Review. Ledbetter, C., Moore, AL., Mitchell, T.[2020]

The RehaCom computerized cognitive training program significantly improved attention and memory functions in 50 brain injury patients after 60 training sessions, with all patients showing enhanced performance in the targeted areas.

The program was well-tolerated, with no reported negative effects such as mental fatigue, headache, or eye irritation, indicating its safety for use in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. Fernández, E., Bringas, ML., Salazar, S., et al.[2022]

Citations

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cochranelibrary.com

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Cognitive Rehabilitation Therapy for Traumatic Brain Injury

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A systematic review by Alashram (32) reported that computerized cognitive training (CCT) improved various cognitive domains in patients with TBI ...