Cognitive Rehabilitation for Traumatic Brain Injury

Overseen By Altaf Saadi, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Severe TBI, Bipolar, Psychosis, others

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

Compensation: Varies

Number of Visits: 9

Duration: 8 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new program can improve thinking and memory skills for refugees who have experienced a traumatic brain injury (TBI). The study will test a virtual cognitive rehabilitation program delivered by trained workers. Participants will be randomly assigned to start the program immediately or after a waiting period. Suitable candidates are refugees who have had a mild or moderate TBI since age 18 and experience memory or concentration difficulties. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance cognitive rehabilitation for others in similar situations.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators.

What prior data suggests that this program is safe for refugees with traumatic brain injury?

Research has shown that trauma-informed cognitive rehabilitation programs are generally safe and well-tolerated for people with traumatic brain injury (TBI). Studies have found that these programs, especially when offered online, effectively improve thinking skills without causing significant side effects. Most participants in past studies reported these programs to be useful and experienced few negative effects.

This study includes online sessions led by community health workers, a method known for addressing gaps in TBI care. Although specific details about side effects for this program aren't provided, similar virtual and community-based programs have been well-received, suggesting they are likely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The trauma-informed, community health worker delivered virtual cognitive rehabilitation program stands out because it offers a new approach to improving cognitive function in individuals with traumatic brain injury (TBI). Unlike traditional in-person therapies, this program uses virtual sessions led by paraprofessionals, making it more accessible and flexible for patients. Researchers are excited about this treatment because it not only addresses cognitive rehabilitation but also integrates trauma-informed care, which considers the psychological impact of TBI and aims for a holistic recovery. By utilizing community health workers, the program also potentially reduces costs and increases the reach of effective cognitive rehabilitation for TBI patients.

What evidence suggests that this cognitive rehabilitation program is effective for traumatic brain injury?

Research has shown that digital programs can improve thinking and memory in people with traumatic brain injury (TBI). A study that combined results from multiple sources found these programs enhance mental skills in TBI patients. Virtual reality training has also helped children with TBI improve skills like planning and problem-solving. Additionally, virtual systems have boosted problem-solving skills and job outcomes for adults with brain injuries. This trial will evaluate a trauma-informed, virtual cognitive rehabilitation program, delivered by a community health worker, to determine its effectiveness in helping refugees with TBI improve their mental abilities. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for refugees and asylum seekers who have experienced a traumatic brain injury (TBI) and are dealing with cognitive issues. Participants should be able to engage in a virtual rehabilitation program aimed at improving thinking and memory.

Inclusion Criteria

I can give my consent verbally.

Identify as an asylum seeker, refugee or have been granted asylum or other form of humanitarian relief

I had a mild or moderate brain injury after turning 18.

Exclusion Criteria

Diagnosis of bipolar, psychosis, active substance use, self-reported current active suicidal ideation or plan

I have been in cognitive rehabilitation recently or am currently.

I had a severe brain injury or one that occurred before I turned 18.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the intervention group complete an 8-session cognitive rehabilitation program delivered virtually by a community health worker

8 weeks

8 virtual sessions

Follow-up

Participants are monitored for satisfaction, acceptability, and effectiveness of the intervention at 1 and 3 months post-intervention

3 months

Assessments at 1 and 3 months

Waitlist Control

Participants in the waitlist control group complete assessments at enrollment, 1 month, and 3 months, with the option to receive the intervention after the final assessment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• A Trauma-informed, Community Health Worker Delivered Virtual Cognitive Rehabilitation Program

Trial Overview The study tests a virtual cognitive rehabilitation program delivered by community health workers. It's designed to see if the program helps improve cognitive functions in TBI patients. Participants will be randomly assigned to either start the program immediately or after three months, with questionnaires tracking their progress.

How Is the Trial Designed?

Group I: Adapted cognitive rehabilitation program intervention Experimental Treatment 1 Intervention

Those in the immediate intervention arm will receive the adapted cognitive rehabilitation therapy program which includes virtual sessions delivered by a paraprofessional focused on improving cognitive function. They will complete baseline assessments (target outcomes and demographic and general health information) and take part in the post-intervention assessments (target outcomes and feasibility, acceptability, and satisfaction measures) at approximately 12 weeks and 24 weeks after baseline.

Group II: Waitlist Control Active Control 1 Intervention

Those in the waitlist control arm will complete baseline assessments (target outcomes and demographic and health information) and receive communications once a week mimicking the contact of the intervention. They will also participate in the post-assessment at approximately 12 weeks, after which they will receive the intervention. After that, they will complete the third assessment, at approximately 24 weeks (target outcomes and feasibility, acceptability, and satisfaction measures)

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Computerized cognitive training (CCT) significantly improved overall cognitive function, attention, and memory in older adults with traumatic brain injury compared to usual care over a 6-month period.

Tai chi (TC) also enhanced cognitive scores and showed lasting benefits, particularly in conceptualization and initiation/preservation, with effects observed up to 12 months, while also improving physical strength and mobility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Computerized Cognitive Training and Tai Chi on Cognitive Performance in Older Adults With Traumatic Brain Injury. Hwang, HF., Chen, CY., Wei, L., et al.[2021]

A pilot study involving 10 individuals with traumatic brain injury (TBI) showed that a computerized brain plasticity-based cognitive training (BPCT) program can be effectively used at home to improve cognitive functioning, with participants reporting subjective improvements and small to large effect sizes on cognitive measures.

The BPCT program was well-received, with minimal technical difficulties and only mild fatigue reported, suggesting it could serve as a beneficial adjunct to traditional neurorehabilitation for TBI patients, even years after their injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of computerized brain plasticity-based cognitive training after traumatic brain injury. Lebowitz, MS., Dams-O'Connor, K., Cantor, JB.[2019]

CogSMART and CCT are effective cognitive training interventions for individuals with traumatic brain injury or neuropsychiatric disorders, showing broad use in real-world settings with high patient satisfaction and attendance rates.

The adaptability of CogSMART/CCT, along with easy access to training manuals, has facilitated its implementation by various healthcare providers, suggesting potential for wider adoption beyond specialized neuropsychologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-method study of the implementation of Cognitive Symptom Management and Rehabilitation Training (CogSMART) in real-world settings. Lindamer, L., Almklov, E., Pittman, JOE., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12537419/

The effectiveness of digital cognitive intervention in patients ... This meta-analysis supports the efficacy of digital cognitive intervention in improving cognitive function in TBI patients. We recommend ...

2. withpower.com withpower.com/trial/cognitive-rehabilitation-for-traumatic-brain-injury-0e5ca

Cognitive Rehabilitation for Traumatic Brain Injury This N/A medical study run by Massachusetts General Hospital is evaluating whether A Trauma-informed, Community Health Worker Delivered Virtual Cognitive ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08049-1

Efficacy of a virtual reality-based cognitive interactive training ... This trial aims to evaluate the efficacy of a virtual reality-based program (VICT) for training executive functions in children with TBI.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06818864

DBS for Cognitive Deficits After Traumatic Brain Injury This study would explore whether a surgical therapy is safe and potentially effective in patients who develop refractory memory and cognitive ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10743630/

Use of Virtual Reality in Patients with Acquired Brain Injury They used this new system to show the viability of improving problem-solving skills and improving professional outcomes for people with TBI [27] ...

6. reporter.nih.gov reporter.nih.gov/project-details/11002729

Project Details - NIH RePORTER The central objective of this research proposal is to optimize and evaluate the first culturally adapted, trauma-informed cognitive rehabilitation intervention ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06188364

Improving Traumatic Brain Injury Rehab Care With Comm ... CHWs are well-suited to fill resource gaps that TBI care partners have difficulty finding, including: (1) finding diagnostic, treatment, and social services; (2) ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11995764/

experiences with Virtual Reality-based cognitive training ... Virtual reality (VR) has been suggested as a promising technology for delivering cognitive training to persons with traumatic brain injury (TBI) ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S0003999325010020?dgcid=rss_sd_all

Can remote digital health interventions improve ... Cognitive rehabilitation post traumatic brain injury: A systematic review for emerging use of virtual reality technology. Journal of Clinical ...