Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06556316

The Brain Injury Neurorehabilitation Project

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic CVA (Cerebrovascular Accident) Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Nervous System Diseases Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Cyprus

Nicosia, 1678, Cyprus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Intervention with the Categorization Program

Behavioral

Cognitive intervention delivered individually. This is a hierarchical cognitive rehabilitation program

Other names: CP

Social Cognitive Communication Program

Behavioral

An 11 week group intervention targeting social and cognitive-communication abilities

Other names: Soc Com

Non-Invasive Brain Stimulation with tDCS

Device

20 minute tDCS intervention as a non-invasive neuromodulation treatment

Other names: tDCS Intervention

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. WHO-BREF Quality of Life

    Time frame: Adminsitered pre & post training at 3 & 6 months follow up

    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.

  2. Depression

    Time frame: Adminisered pre & post training at 3 & 6 months follow up

    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.

Sponsors and collaborators

Lead sponsor

University of Cyprus

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.