Traumatic Brain InjuryNCT06556316
The Brain Injury Neurorehabilitation Project
An observational study of Traumatic Brain Injury and CVA (Cerebrovascular Accident), run by University of Cyprus at 1 site in Cyprus.
Trial summary
The primary objective of The Brain Injury Neurorehabilitation Project is a systematic effort to generate cutting edge research in brain injury and cognitive rehabilitation that will advance neurorehabilitation research. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury, CVA (Cerebrovascular Accident)
- What is being tested?
- Cognitive Intervention with the Categorization Program, Social Cognitive Communication Program and Non-Invasive Brain Stimulation with tDCS
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Jul 2020to 31 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Survivors of ABI (TBI and CVA) who have been hospitalized and are at the chronic phases of their condition. They will be recruited from rehabilitation centers, patient advocacy groups and the major trauma hospital in Cyprus.
Who may be able to join
- moderate to severe TBI or hospitalization due to CVA
Who cannot join
- history of neurodevelopmental disorder, prior neurological history or psychiatric history requiring hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective of The Brain Injury Neurorehabilitation Project is a systematic effort to generate cutting edge research in brain injury and cognitive rehabilitation that will advance neurorehabilitation research. It will establish the first surveillance system and implement multimodal data to characterize the long-term effects of moderate to severe TBI. Additionally, the project will implement innovative rehabilitation methodologies, namely, cognitive training, social communication deficits and non-invasive brain stimulation with tDCS, to determine which modality can improve neurocognitive and psychosocial performance in adult ABI. Two funded projects, BRAIN-REHAB \& ACESO are incorporated in this project.
Read the detailed description
Acquired Brain Injury resulting from a TBI or CVA is a primary cause of chronic disability and unemployment, resulting in significant health, societal, and financial burden. The Brain Injury Neurorehabilitation Project is part of a systematic effort to study ABI in Cyprus. It is an umbrella project designed to generate cutting edge research in brain injury and cognitive rehabilitation that will advance neurorehabilitation research. Patients with TBI and strokes are often faced with cognitive and behavioral difficulties that interfere with their ability to return to productive living, thus contributing to unemployment, social isolation and low quality of life for decades post injury. The scientific objectives will address the aforementioned challenge. First, the project will establish the first TBI surveillance system in Cyprus and implement epidemiologically-principled and systematic data collection from large cohorts across the severity continuum. It will integrate neuropsychological, lifestyle, injury, imaging, genetic, and biological data using state of the art computational methods and quantitatively assess the exact contribution of critical variables to brain injury recovery. Second, the project will determine the effectiveness of a theory-driven neurocognitive therapy program, the Categorization Program (CP) in combination with a social-communication training during the chronic phase of the recovery process. It is hypothesized that the combination of remedial cognitive and social-communication training will yield improvement in functioning with sustainable long term effects. Additionally, the project will implement non-invasive brain stimulation (NIBS) in combination with the social-communication intervention to determine the utility of NIBS and specifically tDCS, in improving cognitive performance and psychosocial functioning. Through innovative research and development of new methods and technologies, the project will advance the State-of-the-Art by producing cutting edge research with international impact while contributing to the development of personalized medicine and improvement of rehabilitation outcomes and reduction of disability in Cyprus.
- Being tested
- Cognitive Intervention with the Categorization Program, Social Cognitive Communication Program, Non-Invasive Brain Stimulation with tDCS
- Keywords
- ABI, CVA, Cognition, Psychosocial, Quality of life, TBI
- Medical subject headings
- Brain Injuries, Traumatic, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Intervention with the Categorization ProgramBehavioural
Also called CP
Cognitive intervention delivered individually. This is a hierarchical cognitive rehabilitation program
Social Cognitive Communication ProgramBehavioural
Also called Soc Com
An 11 week group intervention targeting social and cognitive-communication abilities
Non-Invasive Brain Stimulation with tDCSDevice
Also called tDCS Intervention
20 minute tDCS intervention as a non-invasive neuromodulation treatment
| Study group | Role | What they receive |
|---|---|---|
| Patients with Moderate to Severe TBI who will receive cognitive rehabilitation | Adults with a history of moderate to severe TBI who will receive cognitive rehabilitation through the Categorization Program, a hierarchical remedial intervention Receives: Behavioral: Cognitive Intervention with the Categorization Program | |
| Patients with Moderate to Severe TBI who will receive psychosocial intervention | Adults with a history of moderate to severe TBI who will receive group intervention via the Social Cognitive Communication Program (SocCom) Receives: Behavioral: Social Cognitive Communication Program | |
| Patients with a history of CVA who will receive psychosocial intervention | Adults with a history of CVA (hemorrhagic or ischemic) who will receive group intervention via the Social Cognitive Communication Program (SocCom) Receives: Behavioral: Social Cognitive Communication Program | |
| Patients with a history of CVA who will receive psychosocial intervention and tDCS | Adults with a history of CVA (hemorrhagic or ischemic) who will receive group intervention via the Social Cognitive Communication Program (SocCom) and tDCS treatment Receives: Behavioral: Social Cognitive Communication Program; Device: Non-Invasive Brain Stimulation with tDCS | |
| Patients with TBI who will receive psychosocial intervention & TDCS | Adults with a history of moderate to severe TBI who will receive group intervention via the Social Cognitive Communication Program (SocCom) and tDCS treatment Receives: Behavioral: Social Cognitive Communication Program; Device: Non-Invasive Brain Stimulation with tDCS | |
| Patients with TBI receiving group psychosocial intervention and the Categorization Program | Adults with a history of moderate to severe TBI who will receive cognitive rehabilitation through the CP and group intervention with the SocCom treatment Receives: Behavioral: Cognitive Intervention with the Categorization Program; Behavioral: Social Cognitive Communication Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory
The Greek version of the Auditory Verbal Learning Test will be used as a key outcome for memory. The test consists of a list of 15 items read to the participant, and the participant is required to recall as many items from the list. Maximum score per trial is 15. The process is repeated 5 times (presentation of the list and subsequent recall) for a possible maximum score of 60. A thirty-minute delay is also included after the five learning trials. The measure allows exploring a number of memory processes, such as short term memory (trial one), working memory (list learning across the five trials) and episodic memory (ability to recall items on the list after the 30-minute delay).
Measured: Administered pre & post training at 3 & 6 months follow up
Language
Expressive and receptive language, including naming and verbal fluency, will be used. For this task, we will use the Greek short version of the Peabody Picture Vocabulary test (maximum score of 32) the Greek Short Version of the Boston Naming Test (maximum score of 20). In addition, animal naming in 60 seconds and words from letter F in 60 seconds will be used for verbal fluency. For all tasks, higher scores indicate better performance.
Measured: Administered Pre and Post training at 3 & 6 months follow up
Executive Functioning
Laboratory and structured questionnaires will be used to assess executive functions. Laboratory tests include the Trail Making A and B (performance is measured in seconds; the faster, the better), and the Symbol Digits Modalities task (completion of as many items as possible in 90 seconds; higher score is better). In addition, the Dysexecutive Questionnaire will be completed by the participant and a close informant, to assess everyday executive functioning abilities. Maximum score is 148 and the lower score indicates better executive abilities.
Measured: Administered pre & post training at 3 & 6 months follow up
Secondary outcomes (2)
WHO-BREF Quality of Life
This measure by the World Health Organization is a widely used measure of general quality of life across key domains: Psychological Health, Physical Health, Environment/Support. Higher scores indicate better quality of life. There is no specific cut-off score. Statements are rated on a likert scale. Higher scores indicate greater satisfaction with one's quality of life.
Measured: Adminsitered pre & post training at 3 & 6 months follow up
Depression
The Greek version of the Beck Depression Inventory will be used. Higher scores indicate greater levels of depressive symptomatology. The score of 15 and higher indicates mild levels of depression. Maximum score is 63.
Measured: Adminisered pre & post training at 3 & 6 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start1 Jul 2020
- Primary completion31 Jul 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Cyprus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fofi Constantinidou, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556316
- Sponsor's protocol ID
- Excellence/1216/0411
- Other IDs
- Excellence/0918/0117
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Certain aspects of the study protocol may be shared after publication of study results
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Brain Injury Neurorehabilitation Project
- ClinicalTrials.gov ID
- NCT06556316
- Acronym / sponsor ID
- Excellence/1216/0411
- Keywords
- ABI, CVA, Cognition, Psychosocial, Quality of life, TBI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of CyprusUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Aug 2024 (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.
The primary objective of The Brain Injury Neurorehabilitation Project is a systematic effort to generate cutting edge research in brain injury and cognitive rehabilitation that will advance neurorehabilitation research. It will establish the first surveillance system and implement multimodal data to characterize the long-term effects of moderate to severe TBI. Additionally, the project will implement innovative rehabilitation methodologies, namely, cognitive training, social communication deficits and non-invasive brain stimulation with tDCS, to determine which modality can improve neurocognitive and psychosocial performance in adult ABI. Two funded projects, BRAIN-REHAB \& ACESO are incorporated in this project.
Detailed description
Acquired Brain Injury resulting from a TBI or CVA is a primary cause of chronic disability and unemployment, resulting in significant health, societal, and financial burden. The Brain Injury Neurorehabilitation Project is part of a systematic effort to study ABI in Cyprus. It is an umbrella project designed to generate cutting edge research in brain injury and cognitive rehabilitation that will advance neurorehabilitation research. Patients with TBI and strokes are often faced with cognitive and behavioral difficulties that interfere with their ability to return to productive living, thus contributing to unemployment, social isolation and low quality of life for decades post injury. The scientific objectives will address the aforementioned challenge. First, the project will establish the first TBI surveillance system in Cyprus and implement epidemiologically-principled and systematic data collection from large cohorts across the severity continuum. It will integrate neuropsychological, lifestyle, injury, imaging, genetic, and biological data using state of the art computational methods and quantitatively assess the exact contribution of critical variables to brain injury recovery. Second, the project will determine the effectiveness of a theory-driven neurocognitive therapy program, the Categorization Program (CP) in combination with a social-communication training during the chronic phase of the recovery process. It is hypothesized that the combination of remedial cognitive and social-communication training will yield improvement in functioning with sustainable long term effects. Additionally, the project will implement non-invasive brain stimulation (NIBS) in combination with the social-communication intervention to determine the utility of NIBS and specifically tDCS, in improving cognitive performance and psychosocial functioning. Through innovative research and development of new methods and technologies, the project will advance the State-of-the-Art by producing cutting edge research with international impact while contributing to the development of personalized medicine and improvement of rehabilitation outcomes and reduction of disability in Cyprus.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Patients with Moderate to Severe TBI who will receive cognitive rehabilitation | – | Behavioral: Cognitive Intervention with the Categorization ProgramAdults with a history of moderate to severe TBI who will receive cognitive rehabilitation through the Categorization Program, a hierarchical remedial intervention |
| Patients with Moderate to Severe TBI who will receive psychosocial intervention | – | Behavioral: Social Cognitive Communication ProgramAdults with a history of moderate to severe TBI who will receive group intervention via the Social Cognitive Communication Program (SocCom) |
| Patients with a history of CVA who will receive psychosocial intervention | – | Behavioral: Social Cognitive Communication ProgramAdults with a history of CVA (hemorrhagic or ischemic) who will receive group intervention via the Social Cognitive Communication Program (SocCom) |
| Patients with a history of CVA who will receive psychosocial intervention and tDCS | – | Behavioral: Social Cognitive Communication Program, Device: Non-Invasive Brain Stimulation with tDCSAdults with a history of CVA (hemorrhagic or ischemic) who will receive group intervention via the Social Cognitive Communication Program (SocCom) and tDCS treatment |
| Patients with TBI who will receive psychosocial intervention & TDCS | – | Behavioral: Social Cognitive Communication Program, Device: Non-Invasive Brain Stimulation with tDCSAdults with a history of moderate to severe TBI who will receive group intervention via the Social Cognitive Communication Program (SocCom) and tDCS treatment |
| Patients with TBI receiving group psychosocial intervention and the Categorization Program | – | Behavioral: Cognitive Intervention with the Categorization Program, Behavioral: Social Cognitive Communication ProgramAdults with a history of moderate to severe TBI who will receive cognitive rehabilitation through the CP and group intervention with the SocCom treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Survivors of ABI (TBI and CVA) who have been hospitalized and are at the chronic phases of their condition. They will be recruited from rehabilitation centers, patient advocacy groups and the major trauma hospital in Cyprus.
Key inclusion criteria (1 listed)
- moderate to severe TBI or hospitalization due to CVA
Key exclusion criteria (1 listed)
- history of neurodevelopmental disorder, prior neurological history or psychiatric history requiring hospitalization
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 |
|---|---|---|
| Cognitive Intervention with the Categorization ProgramAlso: CPCognitive intervention delivered individually. This is a hierarchical cognitive rehabilitation program | Behavioural | Patients with Moderate to Severe TBI who will receive cognitive rehabilitation, Patients with TBI receiving group psychosocial intervention and the Categorization Program |
| Social Cognitive Communication ProgramAlso: Soc ComAn 11 week group intervention targeting social and cognitive-communication abilities | Behavioural | Patients with Moderate to Severe TBI who will receive psychosocial intervention, Patients with TBI receiving group psychosocial intervention and the Categorization Program, Patients with TBI who will receive psychosocial intervention & TDCS, Patients with a history of CVA who will receive psychosocial intervention, Patients with a history of CVA who will receive psychosocial intervention and tDCS |
| Non-Invasive Brain Stimulation with tDCSAlso: tDCS Intervention20 minute tDCS intervention as a non-invasive neuromodulation treatment | Device | Patients with TBI who will receive psychosocial intervention & TDCS, Patients with a history of CVA who will receive psychosocial intervention and tDCS |
Primary outcome
Memory
Time frame: Administered pre & post training at 3 & 6 months follow up
The Greek version of the Auditory Verbal Learning Test will be used as a key outcome for memory. The test consists of a list of 15 items read to the participant, and the participant is required to recall as many items from the list. Maximum score per trial is 15. The process is repeated 5 times (presentation of the list and subsequent recall) for a possible maximum score of 60. A thirty-minute delay is also included after the five learning trials. The measure allows exploring a number of memory processes, such as short term memory (trial one), working memory (list learning across the five trials) and episodic memory (ability to recall items on the list after the 30-minute delay).
Language
Time frame: Administered Pre and Post training at 3 & 6 months follow up
Expressive and receptive language, including naming and verbal fluency, will be used. For this task, we will use the Greek short version of the Peabody Picture Vocabulary test (maximum score of 32) the Greek Short Version of the Boston Naming Test (maximum score of 20). In addition, animal naming in 60 seconds and words from letter F in 60 seconds will be used for verbal fluency. For all tasks, higher scores indicate better performance.
Executive Functioning
Time frame: Administered pre & post training at 3 & 6 months follow up
Laboratory and structured questionnaires will be used to assess executive functions. Laboratory tests include the Trail Making A and B (performance is measured in seconds; the faster, the better), and the Symbol Digits Modalities task (completion of as many items as possible in 90 seconds; higher score is better). In addition, the Dysexecutive Questionnaire will be completed by the participant and a close informant, to assess everyday executive functioning abilities. Maximum score is 148 and the lower score indicates better executive abilities.
2 secondary outcomes
WHO-BREF Quality of Life
Time frame: Adminsitered pre & post training at 3 & 6 months follow up
Depression
Time frame: Adminisered pre & post training at 3 & 6 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Individual participant dataSharing planned: Undecided. Certain aspects of the study protocol may be shared after publication of study results
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and CVA (Cerebrovascular Accident), run by University of Cyprus at 1 site in Cyprus.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. 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 Cyprus. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory (time frame: Administered pre & post training at 3 & 6 months follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2024.