Cognitive Training for Traumatic Brain Injury

Overseen By Gerald Voelbel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Schizophrenia, Bipolar, Alcohol, Drug use, others

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

Compensation: Varies

Number of Visits: 4

150 Participants Needed

Trial Summary

What is the purpose of this trial?

This project will examine if computerized cognitive remediation will improve working memory and attention in 25 adults with a mild, moderate, or severe brain injury and compare their cognitive performance to the control group of 25 adults with a mild, moderate, or severe brain injury. The control group will train on computerized tasks of social awareness. Participants in both groups will be assessed prior to training and immediately post-training and one month-post training.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment BrainHQ Cognitive Training Modules for traumatic brain injury?

Research shows that cognitive training programs like RehaCom can improve attention and memory in brain injury patients, with all participants in one study showing better performance after training. Additionally, attention remediation has been found to reduce symptom intensity and improve psychological and social functioning in head injury patients. ^{1 2 3 4 5}

Is cognitive training safe for people with brain injuries?

Research on cognitive training programs like RehaCom and NeuroTrackerX shows they are generally safe, with some reports of mild side effects such as mental fatigue, headache, and eye irritation. These programs have been used successfully in people with brain injuries without significant safety concerns. ^{1 2 3 6 7}

How is the BrainHQ Cognitive Training Modules treatment different from other treatments for traumatic brain injury?

The BrainHQ Cognitive Training Modules are unique because they focus on improving attention, memory, and social skills through interactive exercises, which can be more engaging and accessible compared to traditional therapies. Unlike some treatments that rely on medication, this approach uses cognitive exercises to enhance brain function, making it a non-invasive option for rehabilitation. ^{1 2 3 8 9}

Research Team

Gerald Voelbel, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults over 18 with a medically documented mild, moderate, or severe traumatic brain injury (TBI) who are at least three months post-injury. It excludes those with schizophrenia, bipolar disorder, or current alcohol/drug abuse to avoid cognitive performance interference.

Inclusion Criteria

Free of current alcohol or drug abuse

It has been over 3 months since my injury.

I am older than 18 years.

Exclusion Criteria

Being diagnosed with schizophrenia or bipolar disorder

My injury occurred less than 3 months ago.

A brain injury that is not medically documented

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cognitive Training

Participants undergo 40 sessions of cognitive training, each lasting 45 minutes, conducted remotely with online meetings before and after the training.

8 weeks

2 visits (virtual)

Follow-up

Participants are assessed immediately post-training and 1 month post-training to evaluate changes in cognitive performance.

4 weeks

2 visits (virtual)

Treatment Details

Interventions

• BrainHQ Cognitive Training Modules
• BrainHQ People Skills Modules

Trial Overview The study tests if computerized cognitive remediation can improve working memory and attention in TBI patients. It involves BrainHQ Cognitive Training Modules compared to social awareness tasks in a control group. Assessments occur before training, immediately after, and one month later.

Participant Groups

Group I: BrainHQ People Skills Arm Experimental Treatment 1 Intervention

Participants will be randomized into the BrainHQ People Skills Modules which are 45 minute training sessions. There will be 40 training sessions. Since the intervention is presented both visually and verbally through the computer, and participants will be asked tocomplete the training in a quiet space and time to complete these activities. Participants will complete the 40 training sessions remotely, but will meet with the study team member online prior to beginning the training and right after completing the training.

Group II: BrainHQ Cognitive Training Arm Experimental Treatment 1 Intervention

Participants will be randomized into the BrainHQ Cognitive Training modules which are 45 minute training sessions. There will be 40 training sessions. Since the intervention is presented both visually and verbally through the computer, and participants will be asked if they have a quiet space and noise cancelling headphones. Participants will complete the training protocols remotely and their performance will be tracked. Participants will complete the 40 training sessions remotely, but will meet with the study team member online prior to beginning the training and right after completing the training.

BrainHQ Cognitive Training Modules is already approved in United States, European Union, Canada, China for the following indications:

Approved in United States as Cognitive Rehabilitation for:

• Traumatic Brain Injury
• Improvement of cognitive functions such as attention, memory, and executive functions

Approved in European Union as Cognitive Rehabilitation for:

• Traumatic Brain Injury
• Improvement of cognitive functions such as attention, memory, and executive functions

Approved in Canada as Cognitive Rehabilitation for:

• Traumatic Brain Injury
• Improvement of cognitive functions such as attention, memory, and executive functions

Approved in China as Cognitive Rehabilitation for:

• Traumatic Brain Injury
• Improvement of cognitive functions such as attention, memory, and executive functions

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

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]

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 30 patients with acquired brain injury (ABI), those who underwent specialized inpatient rehabilitation showed significant improvements in cognitive and functional abilities, as measured by the Montreal Cognitive Assessment (MoCA) and Functional Independence Measures (FIM) after 3 weeks of treatment.

Follow-up results indicated that 19 patients maintained their cognitive improvements and further enhanced their functional scores at least 3 months post-discharge, demonstrating the long-term efficacy of the rehabilitation program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive and Functional Outcomes following Inpatient Rehabilitation in Patients with Acquired Brain Injury: A Prospective Follow-up Study. Patil, M., Gupta, A., Khanna, M., et al.[2020]

The new cognitive rehabilitation program REHACOM significantly improved cognitive function in patients with severe head injuries, outperforming both standard neurological therapy and the Wiener Determinationsgerät (WDT) in tests like the HAWIE and BENTON-Test.

REHACOM was particularly effective in enhancing right-hemispheric cognitive functions, suggesting that targeted training in this area is more beneficial than general attentional stimulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Training in cognitive functions in neurologic rehabilitation of craniocerebral trauma]. Friedl-Francesconi, H., Binder, H.[2006]

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]

The study demonstrated that the at-home cognitive training tool NeuroTrackerX is feasible for use among cognitively healthy adults, with high recruitment and retention rates, and 90% adherence to the program over 10 sessions in 5 weeks.

Both the at-home group and the control group showed significant improvements in task performance, indicating that NeuroTrackerX could be an effective therapeutic option for cognitive training, particularly for traumatic brain injury survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Protocol for Remote Cognitive Training Developed for Use in Clinical Populations During the COVID-19 Pandemic. Snowden, T., Ohlhauser, L., Morrison, J., et al.[2023]

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]

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]

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]

References

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

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

2. India pubmed.ncbi.nlm.nih.gov

Remediation of attention deficits in head injury. [2009]

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

Cognitive and Functional Outcomes following Inpatient Rehabilitation in Patients with Acquired Brain Injury: A Prospective Follow-up Study. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

[Training in cognitive functions in neurologic rehabilitation of craniocerebral trauma]. [2006]

5. 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]

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

A Protocol for Remote Cognitive Training Developed for Use in Clinical Populations During the COVID-19 Pandemic. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Cognitive rehabilitation in traumatic brain injury. [2021]

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

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