NCT06556316

The Brain Injury Neurorehabilitation Project

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University of Cyprus · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury
• CVA (Cerebrovascular Accident)

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Intervention with the Categorization Program	Cognitive intervention delivered individually. This is a hierarchical cognitive rehabilitation program
BEHAVIORAL	Social Cognitive Communication Program	An 11 week group intervention targeting social and cognitive-communication abilities
DEVICE	Non-Invasive Brain Stimulation with tDCS	20 minute tDCS intervention as a non-invasive neuromodulation treatment

Timeline

• Start date: 2020-07-01
• Primary completion: 2023-07-31
• Completion: 2025-12-31
• First posted: 2024-08-16
• Last updated: 2024-08-16

Locations

1 site across 1 country: Cyprus