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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to helping Veterans with a history of traumatic brain injury (TBI) improve cognitive skills, such as memory and attention, through technology. Participants will receive GOALS Cognitive Training either at home via telehealth or in person to determine which method is more effective. The trial aims to make health care more accessible and beneficial for older Veterans and to encourage their participation in research. Veterans aged 65 or older who have experienced cognitive issues after a TBI and are comfortable using technology, like computers or smartphones, may be well-suited for this study. As an unphased study, this trial offers Veterans the chance to contribute to innovative research that could enhance cognitive rehabilitation methods.

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 prior data suggests that this cognitive training is safe for Veterans with TBI?

Research has shown that cognitive training programs like GOALS are generally safe for people with traumatic brain injury (TBI). Reviews of digital health tools have found positive results for people with TBI, with no major side effects reported. This indicates that using technology for cognitive training, such as home-based telehealth, is both safe and effective.

For in-person GOALS training, studies have demonstrated that this type of rehabilitation can improve thinking skills affected by brain injury. Participants in similar programs have reported better daily functioning, and studies have not identified any major safety concerns.

Overall, both home-based telehealth and in-person GOALS programs appear to be safe options for helping people with TBI enhance their cognitive skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the GOALS Cognitive Training for traumatic brain injury (TBI) because it offers a flexible approach with its home-based telehealth option. Unlike traditional in-person therapies for TBI, which require patients to travel to clinics, the home-based telehealth GOALS allows participants to receive cognitive training from the comfort of their own home via video calls. This can make treatment more accessible and convenient for those with mobility challenges or who live far from treatment centers. Additionally, the in-person GOALS arm provides a direct comparison to see if remote methods can match or even surpass traditional therapy in effectiveness.

What evidence suggests that GOALS Cognitive Training is effective for cognitive problems associated with TBI?

Studies have shown that cognitive training can improve thinking skills in people with traumatic brain injury (TBI). In this trial, participants will receive either the in-person GOALS treatment or the home-based telehealth GOALS treatment. Research supports the effectiveness of the in-person GOALS treatment in enhancing mental abilities and everyday skills in TBI patients. This cognitive rehabilitation reduces thinking problems and increases functional ability.

For the home-based telehealth GOALS, early findings suggest it can be a practical and acceptable way to provide cognitive training to older Veterans with TBI. While evidence is still growing, telehealth approaches aim to make these therapies more accessible. However, the effectiveness of telehealth treatments for TBI survivors is still under study, and more research is needed to confirm their benefits. ^{6 7 8 9 10}

Who Is on the Research Team?

Erica S. Kornblith, PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04111549

GOALS Cognitive Training Delivered to Aging Veterans in ... This study will use technology to deliver effective treatment for cognitive problems associated with TBI to Veterans at home, which may result in improved ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5824099/

Telehealth Rehabilitation for Cognitive Impairment For those who participated in the intervention, 6 out of 6 goals measured with the Canadian Occupational Performance Measure improved for those in the in-person ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07190365

Goal-oriented Telehealth Rehabilitation of Executive ... This study aims to increase access and availability of evidence-based, in-person administered cognitive rehabilitation training for Veterans ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35656767/

Effectiveness of telehealth interventions among traumatic ... However, the effectiveness of telehealth interventions among TBI survivors remains inconclusive. Methods: A systematic review and meta-analysis ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/23279095.2023.2199160

Telehealth delivery of group-format cognitive rehabilitation ... The adapted TeleGOALS intervention appears highly feasible and acceptable for older Veterans with TBI able and willing to participate in a group-format IVT ...

6. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT04111549

GOALS Cognitive Training Delivered to Aging Veterans in ... This study will use technology to deliver effective treatment for cognitive problems associated with TBI to Veterans at home.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4454274/

Telephone-based goal management training for adults with ... The primary objective of this study is to examine the efficacy of telephone-based GMT for improving executive functioning, functional status, ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05380050?locStr=United+States&country=United+States&aggFilters=status%3A

Study Details | NCT05380050 | Comparing Telehealth to In ... Telehealth delivery of cognitive interventions in Veterans with mTBI or with PTSD has shown effectiveness that is comparable to that of in-person treatment.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12202449/

A comprehensive review of rehabilitation approaches for ... These interventions focus on daily living tasks and social participation, and they have been shown to improve outcomes for people with TBI.

10. journals.sagepub.com journals.sagepub.com/doi/10.1089/neu.2021.0473?int.sj-full-text.similar-articles.8

Cognitive and Behavioral Digital Health Interventions for ... Digital health interventions for people with TBI and their caregivers are feasible and all studies reported positive outcomes; however, few included blind ...