The Brain Injury Neurorehabilitation Project
NCT Number: NCT06556316
Status: ACTIVE_NOT_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Traumatic Brain Injury|CVA (Cerebrovascular Accident)
Interventions: BEHAVIORAL: Cognitive Intervention with the Categorization Program|BEHAVIORAL: Social Cognitive Communication Program|DEVICE: Non-Invasive Brain Stimulation with tDCS
Sponsor: University of Cyprus
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-07-01
Completion Date: 2025-12-31
Locations: University of Cyprus, Nicosia, 1678, Cyprus

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.

Primary Outcome Measures: 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)., 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., 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., Administered pre & post training at 3 & 6 months follow up
Secondary Outcome Measures: 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., 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., Adminisered pre & post training at 3 & 6 months follow up