Cognitive Training for TBI

(TeleGOALS Trial)

Overseen By Erica S Kornblith, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Unstable conditions, Drug abuse, others

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

Compensation: Varies

Number of Visits: 1

29 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will use technology to deliver effective treatment for cognitive problems associated with TBI to Veterans at home, which may result in improved daily functioning and increased access to health care for the growing population of aging Veterans with history of TBI. The successful completion of this project may also increase older Veterans' ability to participate in research through increased understanding of the effect of in-home research opportunities on recruitment and retention. Additionally, the evidence gathered from this study may be used in future research studying home-based cognitive rehabilitation treatments for Veterans using telehealth technology.

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 might be best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment GOALS Cognitive Training for TBI?

Research shows that cognitive training can improve cognitive functions like attention and memory in people with brain injuries. Studies have found that such training leads to modest improvements in overall cognitive and functional outcomes for those with traumatic brain injury. ^{1 2 3 4 5}

Is cognitive training for TBI safe for humans?

The RehaCom cognitive training program, used for brain injury rehabilitation, was assessed for negative effects like mental fatigue, headache, and eye irritation, and was found to be clinically useful with all patients showing improvement. ^{2 3 4 6 7}

How is GOALS Cognitive Training different from other treatments for TBI?

GOALS Cognitive Training is unique because it focuses on improving executive function and emotion regulation by applying attention regulation to participant-defined goals, leading to long-term improvements in cognitive skills and daily functioning, especially in veterans with chronic TBI. ^{1 2 4 8 9}

Research Team

Erica S. Kornblith, PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Eligibility Criteria

This trial is for aging Veterans, 65 or older, with a history of chronic TBI. They must have cognitive complaints affecting daily life and be comfortable with technology or have someone to assist them. It's not for those with severe cognitive impairment, unstable conditions that hinder participation, drug/alcohol abuse, active psychosis, or poor English comprehension.

Inclusion Criteria

A limited number of VA-issued tablets will be available for use by participants who do not have access to a personal computer or other HBT-compatible device

Self-reported cognitive complaints (1 moderate or severe cognitive symptom on the Neurobehavioral Symptom Inventory (NSI) that interferes with daily function)

Endorsement of comfort and familiarity with technology and/or possession of a personal computer, tablet, or smartphone

Exclusion Criteria

I have significant memory or thinking problems affecting my daily life.

Ongoing illicit or prescription drug or alcohol abuse

Active psychosis

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Adaptation

Adaptation of the existing GOALS protocol for home-based telehealth use and use with older Veterans, collecting post-training feasibility and acceptability data

5 weeks

1 visit (virtual)

Pilot

Feasibility, acceptability, cognitive, emotional, and daily functioning data collected from Veterans before and after participation in GOALS training delivered in person or via home-based telehealth

5 weeks

Multiple visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GOALS Cognitive Training

Trial Overview The study tests GOALS Cognitive Training delivered in two ways: directly in-person and via telehealth at home. The goal is to see if this treatment can improve daily functioning and healthcare access for Veterans with TBI by using technology.

Participant Groups

Group I: Home-based telehealth GOALS Experimental Treatment 1 Intervention

Participants in this arm will receive the GOALS intervention via in-home video telehealth.

Group II: In-person GOALS Active Control 1 Intervention

Participants in this arm will receive the GOALS intervention in the traditional in-person format.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

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]

A new movement-discrimination cognitive training method was found to effectively improve both visual timing deficits and high-level cognitive functions in four individuals with mild traumatic brain injury (TBI) over an 8-16 week period.

The training enhanced cognitive skills such as attention, reading fluency, processing speed, and working memory, while brain imaging showed improvements in the brain's dorsal stream and executive control networks, indicating a promising new treatment approach for TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic cognitive remediation for a Traumatic Brain Injury (TBI) significantly improves attention, working memory, processing speed, and reading fluency. Lawton, T., Huang, MX.[2023]

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 training (CT) has a small but statistically significant effect on overall cognition in patients with traumatic brain injury (TBI) more than 12 months post-injury, based on a meta-analysis of 14 studies involving 575 patients.

CT shows a moderate effect on overall functional outcomes and is particularly effective in improving executive function and verbal memory, suggesting it should be more widely integrated into TBI rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Training for Post-Acute Traumatic Brain Injury: A Systematic Review and Meta-Analysis. Hallock, H., Collins, D., Lampit, A., et al.[2020]

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 combination of modified Goal Management Training (mGMT) and the RehaGoal App was found to be feasible for helping individuals with executive function impairments after traumatic brain injury (TBI), with all four participants showing improvement in their self-defined goals over an 8-week intervention.

Participants reported excellent usability of the RehaGoal App, and the collected metrics data provided valuable insights into user behavior, suggesting that the app could effectively support rehabilitation efforts and may be suitable for larger studies in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guiding patients with traumatic brain injury through the instrumental activities of daily living with the RehaGoal App: a feasibility study. Ertas-Spantgar, F., Korabova, S., Gabel, A., et al.[2022]

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]

A study involving 24 Veterans with chronic traumatic brain injury (TBI) showed that long-term executive function training (GOALS) led to significant improvements in attention, functional task performance, and emotional regulation, assessed over 6+ months after training.

Participants reported a notable increase in their likelihood of engaging in competitive employment or volunteering, rising from 26% at baseline to 61% at follow-up, indicating the training's positive impact on daily functioning and quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term effects of executive function training among veterans with chronic TBI. Novakovic-Agopian, T., Kornblith, E., Abrams, G., et al.[2021]

Impairment training for cognitive disorders after right hemisphere stroke can provide some benefits, but its effectiveness is limited due to cognitive constraints and brain damage.

Task specific training, especially when combined with various cognitive principles, shows more promise for improving performance, although more research is needed to fully understand its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elements of cognitive rehabilitation after right hemisphere stroke. Calvanio, R., Levine, D., Petrone, P.[2006]

References

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

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

Dynamic cognitive remediation for a Traumatic Brain Injury (TBI) significantly improves attention, working memory, processing speed, and reading fluency. [2023]

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

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

4. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Training for Post-Acute Traumatic Brain Injury: A Systematic Review and Meta-Analysis. [2020]

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

Role and impact of cognitive rehabilitation. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Guiding patients with traumatic brain injury through the instrumental activities of daily living with the RehaGoal App: a feasibility study. [2022]

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

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

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

Long-term effects of executive function training among veterans with chronic TBI. [2021]

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

Elements of cognitive rehabilitation after right hemisphere stroke. [2006]