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

Trial Summary

What is the purpose of this trial?

Researchers at Massachusetts General Hospital are looking to see if a program created to help improve thinking and memory can work for refugees and asylum seekers with traumatic brain injury (TBI). They're checking if this program is practical and if people find it helpful. The study will have two groups, and people will be assigned to a group by chance. One group will participate in the program and answer questionnaires before starting the program and then one month and three months after the end of the program. The other group will answer a questionnaire after they enroll, then one month and three months after enrollment. People in this second group will have the option to participate in the program after three months.

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 data supports the effectiveness of the treatment for cognitive rehabilitation in traumatic brain injury?

Research shows that computerized brain training and telehealth cognitive rehabilitation programs can help improve cognitive function in people with traumatic brain injury. Participants in these studies reported feeling better and showed improvements in cognitive tests, suggesting that virtual cognitive rehabilitation can be effective. ^{1 2 3 4 5}

Is cognitive rehabilitation for traumatic brain injury safe for humans?

The studies suggest that cognitive rehabilitation programs, including computerized and telehealth formats, are generally safe for people with traumatic brain injury. Some participants reported mild fatigue, but it tended to go away over time, and no serious safety concerns were noted. ^{1 2 4 6 7}

How is the Trauma-informed, Community Health Worker Delivered Virtual Cognitive Rehabilitation Program different from other treatments for traumatic brain injury?

This treatment is unique because it is delivered virtually by community health workers, making it accessible for patients to receive cognitive rehabilitation at home. It focuses on a trauma-informed approach, which means it considers the emotional and psychological impact of traumatic brain injury, unlike traditional methods that may not address these aspects. ^{1 2 4 6 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Those in the intervention arm will receive the adapted cognitive rehabilitation therapy program which includes virtual sessions delivered by a community health worker 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).

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 take part in the post-intervention assessments (target outcomes and feasibility, acceptability, and satisfaction measures), after which they will have the option to receive the intervention.

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+

Findings from Research

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]

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]

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]

References

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

Feasibility of computerized brain plasticity-based cognitive training after traumatic brain injury. [2019]

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

Telehealth delivery of group-format cognitive rehabilitation to older veterans with TBI: a mixed-methods pilot study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Telerehabilitation for addressing executive dysfunction after traumatic brain injury. [2022]

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

Cognitive and Behavioral Digital Health Interventions for People with Traumatic Brain Injury and Their Caregivers: A Systematic Review. [2023]

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

Effectiveness of Interventions to Address Cognitive Impairments and Improve Occupational Performance After Traumatic Brain Injury: A Systematic Review. [2019]

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

Current practice of cognitive rehabilitation following traumatic brain injury: An international survey. [2021]

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

Effects of Computerized Cognitive Training and Tai Chi on Cognitive Performance in Older Adults With Traumatic Brain Injury. [2021]

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

Multi-method study of the implementation of Cognitive Symptom Management and Rehabilitation Training (CogSMART) in real-world settings. [2022]