TBI (Traumatic Brain Injury)NCT06839079
Cognitive Rehabilitation for Victims of War and Related Traumas With Traumatic Brain Injury and Cognitive Impairment
A study testing A Trauma-informed, Paraprofessional Delivered Virtual Cognitive Rehabilitation Program in people with TBI (Traumatic Brain Injury) and Cognitive Symptoms, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Researchers at Massachusetts General Hospital are looking to see if a program created to help improve thinking and memory can work for people affected by trauma, including asylum seekers and refugees, survivors of intimate partner violence (IPV) and others with traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- TBI (Traumatic Brain Injury), Cognitive Symptoms
- What is being tested?
- A Trauma-informed, Paraprofessional Delivered Virtual Cognitive Rehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Identify as asylum-seekers or refugees, survivors of intimate partner violence (IPV), OR report personal history of other trauma 3. Mild or moderate TBI sustained after the age of 18 4. Age 18-65 5. Subjective cognitive impairment 6. English or Spanish language proficiency 7. Ability to provide verbal informed consent 8. Ability and willingness to answer questionnaires and participation in the Intervention
Who cannot join
- Participation in cognitive rehabilitation treatment current or in past 3 months
- Severe TBI or TBI only sustained under the age of 18
- Diagnosis of bipolar, psychosis, active substance use, self-reported current active suicidal ideation (Potential participants can be screened again after 30 days in the case of suicidal ideation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Margarita G Velasco, MA, 617-724-4957, saadilab@mgh.harvard.edu
About this study
Official title: Feasibility RCT of an Adapted Cognitive Rehabilitation Program for Victims of War and Related Traumas With TBI and Cognitive Impairment
Researchers at Massachusetts General Hospital are looking to see if a program created to help improve thinking and memory can work for people affected by trauma, including asylum seekers and refugees, survivors of intimate partner violence (IPV) and others 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. Participants will complete a first questionnaire and then be assigned to a group by chance. One group will participate in the program immediately and then answer the second questionnaire (approximately 3 months after the first questionnaire they did). Then they will wait and then answer the third and final questionnaire approximately 6 months after the first one.
The second group will wait and answer the second questionnaire approximately 3 months after the first one. Then they will receive the program and answer the third and final questionnaire (approximately 6 months after the first one they did.)
Read the detailed description
There are many refugees and asylum seekers in the world ("refugees" from here on for simplicity). Many of them have suffered from traumatic brain injury (TBI) as a result of traumatic experiences like torture and interpersonal violence. TBI also impacts other populations impacted by trauma, irrespective of their immigration status. For example, this includes survivors of intimate partner violence. Due to their trauma exposure, they encounter overlapping issues as asylum-seekers and refugees, such as their TBI-related symptoms being overlooked due to their psychiatric history, IPV and TBI-related stigma, and under-detection and under-treatment of their TBI-related symptoms. Therefore, we look at trauma-exposed populations collectively as "victims of war and related traumas" or "trauma-exposed populations" to be succinct.
Because of one or more TBI's, they can experience cognitive issues, or issues with learning, thinking, concentration and memory. Cognitive rehabilitation can be one effective way to reduce the burden of cognitive issues following TBI. Cognitive rehabilitation refers to a functionally oriented service of cognitive activities that can aim to lessen cognitive impairments or lessen the disabling impact of these impairments. Yet not all people access cognitive rehabilitation equally. We have tailored an existing cognitive rehabilitation program to be delivered virtually and through a paraprofessional for trauma-exposed populations with TBI and cognitive issues. A paraprofessional refers to a person from the community who does not have specialized medical training.
This is a pilot feasibility randomized trial where English and Spanish-speaking participants will be randomized to either the adapted intervention (n = 25) or a wait-list control (n = 25) in the first stage. The participants in the adapted intervention will receive the intervention first while people in the wait-list control wait. People in the waitlist control will receive the intervention after approximately 12 weeks. All participants will have assessments at baseline, approximately 12 weeks, and 24 weeks after baseline.
During the intervention, participants will complete a program that involves 8 sessions. The sessions will cover material relating to cognitive rehabilitation, such as exercises relating to external or internal memory strategies, aimed to improve cognitive challenges people with TBI experience.
Participants assigned to the immediate intervention will receive the program and then answer the second questionnaire, approximately 12-weeks after their baseline. They will complete the third questionnaire approximately 24-weeks after their baseline
Participants assigned to the waitlist control group will answer the baseline and second questionnaire 12 weeks after. They will then receive the intervention and complete the third questionnaire, approximately 24-weeks after their baseline.
- Conditions
- TBI (Traumatic Brain Injury), Cognitive Symptoms
- Being tested
- A Trauma-informed, Paraprofessional Delivered Virtual Cognitive Rehabilitation Program
- Keywords
- Traumatic Brain Injury, Cognition, Refugees, Asylum Seekers, IPV, trauma-exposed populations
- Medical subject headings
- Brain Injuries, Traumatic, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Trauma-informed, Paraprofessional Delivered Virtual Cognitive Rehabilitation ProgramBehavioural
The intervention will involve 8 proposed individual sessions conducted virtually by a trained bilingual paraprofessional. The intervention will be provided in English or Spanish depending on the participant's preference. The sessions cover psychoeducation about TBI and related symptoms like depression and anxiety, and cognitive activities to address cognitive symptoms (e.g., relaxation strategies and exercises around improving attention, concentration, learning, and memory). Each session covers the topic, real-life examples and practice, and exercises to do outside of the sessions.
| Study group | Role | What they receive |
|---|---|---|
| Adapted cognitive rehabilitation program intervention | Experimental | 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. Receives: Behavioral: A Trauma-informed, Paraprofessional Delivered Virtual Cognitive Rehabilitation Program |
| Waitlist Control | No 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the intervention
At least 70% of participants will complete 7 or more sessions. At least 70% of participants will complete their homework. At least 80% of participants will complete the study and 12 weeks assessment. At least 60% of participants will complete the 24 weeks assessment.
Measured: Through Intervention participation, an average of 8 weeks, and at the 12 weeks and 24 weeks follow-up questionnaires.
Acceptability of the intervention
At least 70% of participants will score over the midpoint in the 4-item Acceptability of Intervention Measure. The AIM scale values range from 1 to 5 with a higher score of 20. Higher scores indicate greater acceptability.
Measured: After the intervention at the 12 weeks and 24 weeks follow-up questionnaires.
Feasibility of the intervention
At least 80% of people approached will agree to participate (feasibility of recruitment).
At least 70% of participants will have no measures fully missing (feasibility of assessments).
Measured: Baseline, and through Intervention participation, an average of 8 weeks.
Feasibility of the intervention
At least 70% of participants will score over the midpoint in the 4-item Feasibility of Intervention Measure (FIM). The FIM is a scale whose values range from 1-5 and a higher score of 20. Higher scores indicate greater acceptability.
Measured: After the intervention at 12 weeks and 24 weeks follow-up questionnaires.
Satisfaction with the intervention
At least 70% of participants will score over the midpoint in the Client Satisfaction Questionnaire (CSQ-8). Scores for the CSQ-8 range from 8 to 32 and higher scores indicate greater satisfaction.
Measured: After the intervention at the, 12 weeks and 24 weeks follow-up questionnaires.
Secondary outcomes (5)
Potential effectiveness on reducing cognitive impairment symptoms in objective measures
Improvement in cognitive function will be assessed through changes on Montreal Cognitive Assessment (MoCA). The MoCA's highest possible score is 30; a score of 26 and higher is considered normal and lower than this cut off will indicate possible cognitive impairment
Measured: Baseline, 12 weeks and 24 weeks follow-up questionnaires
Potential effectiveness on reducing cognitive impairment symptoms in objective measures
Improvement in cognitive function will be assessed through changes on:
Rowland Universal Dementia Assessment Scale (RUDAS) measure. The RUDAS maximum score is 30; a score of 23 and higher is considered normal and lower than this cut off will indicate possible cognitive impairment.
Measured: Baseline, 12 weeks and 24 weeks follow-up questionnaires
Potential effectiveness on reducing cognitive impairment symptoms in subjective measures
Improvement in cognitive function will be assessed through changes in:
PROMIS (Patient Reported Outcome Measurement Information System) Short Form v2.0 - Cognitive Function 8a scale. The scale uses a T score metric where 50 is the mean (the average for the United States general population) and 10 is the standard deviation above or below the mean. A higher score indicates better cognitive performance.
Measured: Baseline, 12 weeks and 24 weeks follow-up questionnaires
Potential effectiveness on reducing cognitive impairment symptoms in subjective measures
Improvement in cognitive function will be assessed through changes in the cognitive questions of Neurobehavioral Symptom Inventory (NSI). The NSI total score ranges from 0 to 88 and it can provide raw scores for four domains, one of them cognitive. A higher score indicates more severe post-concussive symptoms.
Measured: Baseline, 12 weeks and 24 weeks follow-up questionnaires
Potential effectiveness on reducing post-concussive symptoms
Improvement in post-concussive symptoms will be measured using the Neurobehavioral Symptom Inventory (NSI). The NSI total score ranges from 0 to 88. A higher score indicates more severe post-concussive symptoms.
Measured: Baseline, 12 weeks and 24 weeks follow-up questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start15 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of two groups: Group A will receive the intervention immediately. Group B will initially not receive the intervention (waitlist control). After approximately 12 weeks period, Group B will receive the intervention (delayed start). All participants will complete questionnaires at three time points: Baseline (after enrollment) Approximately 12 weeks after baseline. Approximately 24 weeks after baseline.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Altaf Saadi, MD MSc, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06839079
- Sponsor's protocol ID
- 2024P002728
- Other IDs
- K23NS128164
- Status last verified
- Jul 2026
- First submitted
- 4 Feb 2025
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of individual participant data collected during the trial, after deidentification
Publications
Fauza S, Velasco M, Valera E, Saadi A. Traumatic brain injury-related stigma among intimate partner violence survivors. Brain Inj. 2026 Jun;40(8):674-683. doi: 10.1080/02699052.2026.2649542. Epub 2026 Apr 6.
PubMed 41937583Parvez A, Percac-Lima S, Saadi A. The Presence and Profile of Neurological Conditions and Associated Psychiatric Comorbidities in U.S. Resettled Refugees: A Retrospective Single Center Study. J Immigr Minor Health. 2023 Apr;25(2):365-373. doi: 10.1007/s10903-022-01409-6. Epub 2022 Oct 17.
PubMed 36251204Sherman Rosa S, Nadal R, Saadi A. Research Letter: Assessing Traumatic Brain Injury in Refugees: Feasibility, Usability, and Prevalence Insights From a US-Based Clinical Sample. J Head Trauma Rehabil. 2025 Jul-Aug 01;40(4):E334-E339. doi: 10.1097/HTR.0000000000001037. Epub 2025 Jul 1.
PubMed 39874279Saadi A, Williams J, Parvez A, Alegria M, Vranceanu AM. Head Trauma in Refugees and Asylum Seekers: A Systematic Review. Neurology. 2023 May 23;100(21):e2155-e2169. doi: 10.1212/WNL.0000000000207261. Epub 2023 Apr 5.
PubMed 37019660Saadi A, Asfour J, Vassimon De Assis M, Wilson T, Haar RJ, Heisler M. Head Injury and Associated Sequelae in Individuals Seeking Asylum in the United States: A Retrospective Mixed-Methods Review of Medico-Legal Affidavits. Brain Sci. 2024 Jun 14;14(6):599. doi: 10.3390/brainsci14060599.
PubMed 38928599Jahan N, Velasco M, Vranceanu AM, Alegria M, Saadi A. Clinician perspectives on characteristics and care of traumatic brain injury among asylum seekers and refugees. Disabil Rehabil. 2025 Feb;47(3):666-675. doi: 10.1080/09638288.2024.2356014. Epub 2024 Jun 3.
PubMed 38831593
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility RCT of an Adapted Cognitive Rehabilitation Program for Victims of War and Related Traumas With TBI and Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06839079
- Acronym / sponsor ID
- 2024P002728
- Conditions
- TBI (Traumatic Brain Injury), Cognitive Symptoms
- Keywords
- Traumatic Brain Injury, Cognition, Refugees, Asylum Seekers, IPV, trauma-exposed populations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers at Massachusetts General Hospital are looking to see if a program created to help improve thinking and memory can work for people affected by trauma, including asylum seekers and refugees, survivors of intimate partner violence (IPV) and others 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. Participants will complete a first questionnaire and then be assigned to a group by chance. One group will participate in the program immediately and then answer the second questionnaire (approximately 3 months after the first questionnaire they did). Then they will wait and then answer the third and final questionnaire approximately 6 months after the first one.
The second group will wait and answer the second questionnaire approximately 3 months after the first one. Then they will receive the program and answer the third and final questionnaire (approximately 6 months after the first one they did.)
Detailed description
There are many refugees and asylum seekers in the world ("refugees" from here on for simplicity). Many of them have suffered from traumatic brain injury (TBI) as a result of traumatic experiences like torture and interpersonal violence. TBI also impacts other populations impacted by trauma, irrespective of their immigration status. For example, this includes survivors of intimate partner violence. Due to their trauma exposure, they encounter overlapping issues as asylum-seekers and refugees, such as their TBI-related symptoms being overlooked due to their psychiatric history, IPV and TBI-related stigma, and under-detection and under-treatment of their TBI-related symptoms. Therefore, we look at trauma-exposed populations collectively as "victims of war and related traumas" or "trauma-exposed populations" to be succinct.
Because of one or more TBI's, they can experience cognitive issues, or issues with learning, thinking, concentration and memory. Cognitive rehabilitation can be one effective way to reduce the burden of cognitive issues following TBI. Cognitive rehabilitation refers to a functionally oriented service of cognitive activities that can aim to lessen cognitive impairments or lessen the disabling impact of these impairments. Yet not all people access cognitive rehabilitation equally. We have tailored an existing cognitive rehabilitation program to be delivered virtually and through a paraprofessional for trauma-exposed populations with TBI and cognitive issues. A paraprofessional refers to a person from the community who does not have specialized medical training.
This is a pilot feasibility randomized trial where English and Spanish-speaking participants will be randomized to either the adapted intervention (n = 25) or a wait-list control (n = 25) in the first stage. The participants in the adapted intervention will receive the intervention first while people in the wait-list control wait. People in the waitlist control will receive the intervention after approximately 12 weeks. All participants will have assessments at baseline, approximately 12 weeks, and 24 weeks after baseline.
During the intervention, participants will complete a program that involves 8 sessions. The sessions will cover material relating to cognitive rehabilitation, such as exercises relating to external or internal memory strategies, aimed to improve cognitive challenges people with TBI experience.
Participants assigned to the immediate intervention will receive the program and then answer the second questionnaire, approximately 12-weeks after their baseline. They will complete the third questionnaire approximately 24-weeks after their baseline
Participants assigned to the waitlist control group will answer the baseline and second questionnaire 12 weeks after. They will then receive the intervention and complete the third questionnaire, approximately 24-weeks after their baseline.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two groups: Group A will receive the intervention immediately. Group B will initially not receive the intervention (waitlist control). After approximately 12 weeks period, Group B will receive the intervention (delayed start). All participants will complete questionnaires at three time points: Baseline (after enrollment) Approximately 12 weeks after baseline. Approximately 24 weeks after baseline.
| Arm | Type | Receives |
|---|---|---|
| Adapted cognitive rehabilitation program intervention | Experimental | Behavioral: A Trauma-informed, Paraprofessional Delivered Virtual Cognitive Rehabilitation ProgramThose 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. |
| Waitlist Control | No 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 may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Identify as asylum-seekers or refugees, survivors of intimate partner violence (IPV), OR report personal history of other trauma 3. Mild or moderate TBI sustained after the age of 18 4. Age 18-65 5. Subjective cognitive impairment 6. English or Spanish language proficiency 7. Ability to provide verbal informed consent 8. Ability and willingness to answer questionnaires and participation in the Intervention
Key exclusion criteria (3 listed)
- Participation in cognitive rehabilitation treatment current or in past 3 months
- Severe TBI or TBI only sustained under the age of 18
- Diagnosis of bipolar, psychosis, active substance use, self-reported current active suicidal ideation (Potential participants can be screened again after 30 days in the case of suicidal ideation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A Trauma-informed, Paraprofessional Delivered Virtual Cognitive Rehabilitation ProgramThe intervention will involve 8 proposed individual sessions conducted virtually by a trained bilingual paraprofessional. The intervention will be provided in English or Spanish depending on the participant's preference. The sessions cover psychoeducation about TBI and related symptoms like depression and anxiety, and cognitive activities to address cognitive symptoms (e.g., relaxation strategies and exercises around improving attention, concentration, learning, and memory). Each session covers the topic, real-life examples and practice, and exercises to do outside of the sessions. | Behavioural | Adapted cognitive rehabilitation program intervention |
Primary outcome
Acceptability of the intervention
Time frame: Through Intervention participation, an average of 8 weeks, and at the 12 weeks and 24 weeks follow-up questionnaires.
At least 70% of participants will complete 7 or more sessions. At least 70% of participants will complete their homework. At least 80% of participants will complete the study and 12 weeks assessment. At least 60% of participants will complete the 24 weeks assessment.
Acceptability of the intervention
Time frame: After the intervention at the 12 weeks and 24 weeks follow-up questionnaires.
At least 70% of participants will score over the midpoint in the 4-item Acceptability of Intervention Measure. The AIM scale values range from 1 to 5 with a higher score of 20. Higher scores indicate greater acceptability.
Feasibility of the intervention
Time frame: Baseline, and through Intervention participation, an average of 8 weeks.
At least 80% of people approached will agree to participate (feasibility of recruitment). At least 70% of participants will have no measures fully missing (feasibility of assessments).
Feasibility of the intervention
Time frame: After the intervention at 12 weeks and 24 weeks follow-up questionnaires.
At least 70% of participants will score over the midpoint in the 4-item Feasibility of Intervention Measure (FIM). The FIM is a scale whose values range from 1-5 and a higher score of 20. Higher scores indicate greater acceptability.
Satisfaction with the intervention
Time frame: After the intervention at the, 12 weeks and 24 weeks follow-up questionnaires.
At least 70% of participants will score over the midpoint in the Client Satisfaction Questionnaire (CSQ-8). Scores for the CSQ-8 range from 8 to 32 and higher scores indicate greater satisfaction.
5 secondary outcomes
Potential effectiveness on reducing cognitive impairment symptoms in objective measures
Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires
Potential effectiveness on reducing cognitive impairment symptoms in objective measures
Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires
Potential effectiveness on reducing cognitive impairment symptoms in subjective measures
Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires
Potential effectiveness on reducing cognitive impairment symptoms in subjective measures
Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires
Potential effectiveness on reducing post-concussive symptoms
Time frame: Baseline, 12 weeks and 24 weeks follow-up questionnaires
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Background: PubMed 41937583Fauza S, Velasco M, Valera E, Saadi A. Traumatic brain injury-related stigma among intimate partner violence survivors. Brain Inj. 2026 Jun;40(8):674-683. doi: 10.1080/02699052.2026.2649542. Epub 2026 Apr 6.
- Background: PubMed 36251204Parvez A, Percac-Lima S, Saadi A. The Presence and Profile of Neurological Conditions and Associated Psychiatric Comorbidities in U.S. Resettled Refugees: A Retrospective Single Center Study. J Immigr Minor Health. 2023 Apr;25(2):365-373. doi: 10.1007/s10903-022-01409-6. Epub 2022 Oct 17.
- Background: PubMed 39874279Sherman Rosa S, Nadal R, Saadi A. Research Letter: Assessing Traumatic Brain Injury in Refugees: Feasibility, Usability, and Prevalence Insights From a US-Based Clinical Sample. J Head Trauma Rehabil. 2025 Jul-Aug 01;40(4):E334-E339. doi: 10.1097/HTR.0000000000001037. Epub 2025 Jul 1.
- Background: PubMed 37019660Saadi A, Williams J, Parvez A, Alegria M, Vranceanu AM. Head Trauma in Refugees and Asylum Seekers: A Systematic Review. Neurology. 2023 May 23;100(21):e2155-e2169. doi: 10.1212/WNL.0000000000207261. Epub 2023 Apr 5.
- Background: PubMed 38928599Saadi A, Asfour J, Vassimon De Assis M, Wilson T, Haar RJ, Heisler M. Head Injury and Associated Sequelae in Individuals Seeking Asylum in the United States: A Retrospective Mixed-Methods Review of Medico-Legal Affidavits. Brain Sci. 2024 Jun 14;14(6):599. doi: 10.3390/brainsci14060599.
- Background: PubMed 38831593Jahan N, Velasco M, Vranceanu AM, Alegria M, Saadi A. Clinician perspectives on characteristics and care of traumatic brain injury among asylum seekers and refugees. Disabil Rehabil. 2025 Feb;47(3):666-675. doi: 10.1080/09638288.2024.2356014. Epub 2024 Jun 3.
- Individual participant dataSharing planned: Yes. All of individual participant data collected during the trial, after deidentification
Related trials for TBI (Traumatic Brain Injury)
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Trauma-informed, Paraprofessional Delivered Virtual Cognitive Rehabilitation Program in people with TBI (Traumatic Brain Injury) and Cognitive Symptoms, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Altaf Saadi, MD (6177363016, ASAADI@MGH.HARVARD.EDU), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the intervention (time frame: Through Intervention participation, an average of 8 weeks, and at the 12 weeks and 24 weeks follow-up questionnaires.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06839079, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.