The Brain Injury Neurorehabilitation Project

University of Cyprus

Status: Active, not recruiting

Conditions: Traumatic Brain Injury; CVA (Cerebrovascular Accident)

Treatments: Behavioral: Social Cognitive Communication Program; Behavioral: Cognitive Intervention with the Categorization Program; Device: Non-Invasive Brain Stimulation with tDCS

Study type: Observational

Funder types: Other

Identifiers

NCT06556316

Excellence/1216/0411

Excellence/0918/0117 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 6 patient groups

Patients with Moderate to Severe TBI who will receive cognitive rehabilitation

Description:

Adults with a history of moderate to severe TBI who will receive cognitive rehabilitation through the Categorization Program, a hierarchical remedial intervention

Treatment:

Behavioral: Cognitive Intervention with the Categorization Program

Patients with Moderate to Severe TBI who will receive psychosocial intervention

Description:

Adults with a history of moderate to severe TBI who will receive group intervention via the Social Cognitive Communication Program (SocCom)

Treatment:

Behavioral: Social Cognitive Communication Program

Patients with a history of CVA who will receive psychosocial intervention

Description:

Adults with a history of CVA (hemorrhagic or ischemic) who will receive group intervention via the Social Cognitive Communication Program (SocCom)

Treatment:

Behavioral: Social Cognitive Communication Program

Patients with a history of CVA who will receive psychosocial intervention and tDCS

Description:

Adults with a history of CVA (hemorrhagic or ischemic) who will receive group intervention via the Social Cognitive Communication Program (SocCom) and tDCS treatment

Treatment:

Device: Non-Invasive Brain Stimulation with tDCS

Behavioral: Social Cognitive Communication Program

Patients with TBI who will receive psychosocial intervention & TDCS

Description:

Adults with a history of moderate to severe TBI who will receive group intervention via the Social Cognitive Communication Program (SocCom) and tDCS treatment

Treatment:

Device: Non-Invasive Brain Stimulation with tDCS

Behavioral: Social Cognitive Communication Program

Patients with TBI receiving group psychosocial intervention and the Categorization Program

Description:

Adults with a history of moderate to severe TBI who will receive cognitive rehabilitation through the CP and group intervention with the SocCom treatment

Treatment:

Behavioral: Cognitive Intervention with the Categorization Program

Behavioral: Social Cognitive Communication Program