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

77 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to investigate the efficacy of a structured rehabilitation program on cognitive function and quality of life in individuals with blast-induced traumatic brain injury (bTBI).

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.

What data supports the effectiveness of the treatment Cognitive Rehabilitation for Traumatic Brain Injury?

Research shows that cognitive rehabilitation can help people with traumatic brain injury by improving their thinking skills, mood, and ability to participate in work and community activities. Studies have found that programs like RehaCom and ThinkRx, which involve computer-based and clinician-delivered training, lead to improvements in memory, attention, and other cognitive functions. ^{1 2 3 4 5}

Is cognitive rehabilitation safe for humans?

Cognitive rehabilitation is generally considered safe for humans, as it involves structured therapeutic activities to improve thinking and emotional skills. However, safety concerns can arise from the cognitive impairments themselves, such as difficulties with daily tasks or decision-making, so it's important for healthcare professionals to provide education and prevention counseling to limit any risks. ^{1 6 7 8 9}

How is the Cognitive Rehabilitation treatment for traumatic brain injury different from other treatments?

Cognitive Rehabilitation for traumatic brain injury is unique because it focuses on retraining the brain to improve cognitive functions like memory, attention, and problem-solving through personalized exercises and strategies, rather than relying solely on medication. It often involves a combination of techniques, including virtual reality and computerized programs, to enhance recovery and improve daily functioning. ^{1 3 10 11 12}

Research Team

Yelena Bogdanova, PhD PhD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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 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]

References

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

Role and impact of cognitive rehabilitation. [2022]

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

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. [2022]

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

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

4. India pubmed.ncbi.nlm.nih.gov

Remediation of attention deficits in head injury. [2009]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Effects of ThinkRx Cognitive Rehabilitation Training for Eleven Soldiers with Brain Injury: A Retrospective Chart Review. [2020]

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

Patient safety considerations in the rehabilitation of the individual with cognitive impairment. [2012]

7. England 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. [2019]

8. England pubmed.ncbi.nlm.nih.gov

A survey of accredited and other rehabilitation facilities: education, training and cognitive rehabilitation in brain-injury programmes. [2019]

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

Integrating cognitive strategies into the physical therapy setting. [2019]

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

Cognitive Impairment and Rehabilitation Strategies After Traumatic Brain Injury. [2022]

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

Effect of computerized cognitive rehabilitation in comparison between young and old age after traumatic brain injury. [2023]

12. Scotland pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation post traumatic brain injury: A systematic review for emerging use of virtual reality technology. [2019]