Clinical trial NCT06556316: The Brain Injury Neurorehabilitation Project
Official title: The Brain Injury Neurorehabilitation Project
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Traumatic Brain Injury
CVA (Cerebrovascular Accident)
Keywords: ABI
CVA
Cognition
Psychosocial
Quality of life
TBI
Lead sponsor: University of Cyprus
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* moderate to severe TBI or hospitalization due to CVA

Exclusion Criteria:

* history of neurodevelopmental disorder, prior neurological history or psychiatric history requiring hospitalization

Primary outcomes:
measure: Memory
timeFrame: Administered pre & post training at 3 & 6 months follow up
measure: Language
timeFrame: Administered Pre and Post training at 3 & 6 months follow up
measure: Executive Functioning
timeFrame: Administered pre & post training at 3 & 6 months follow up
Secondary outcomes:
measure: WHO-BREF Quality of Life
timeFrame: Adminsitered pre & post training at 3 & 6 months follow up
measure: Depression
timeFrame: Adminisered pre & post training at 3 & 6 months follow up
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: University of Cyprus
Study officials:
References: