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The Brain Injury Neurorehabilitation Project

NCT ID: NCT06556316

Last Updated: 2024-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Traumatic Brain Injury CVA (Cerebrovascular Accident)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with Moderate to Severe TBI who will receive cognitive rehabilitation

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

Cognitive Intervention with the Categorization Program

Intervention Type BEHAVIORAL

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

Patients with Moderate to Severe TBI who will receive psychosocial intervention

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

Social Cognitive Communication Program

Intervention Type BEHAVIORAL

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

Patients with a history of CVA who will receive psychosocial intervention

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

Social Cognitive Communication Program

Intervention Type BEHAVIORAL

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

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

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

Social Cognitive Communication Program

Intervention Type BEHAVIORAL

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

Non-Invasive Brain Stimulation with tDCS

Intervention Type DEVICE

20 minute tDCS intervention as a non-invasive neuromodulation treatment

Patients with TBI who will receive psychosocial intervention & TDCS

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

Social Cognitive Communication Program

Intervention Type BEHAVIORAL

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

Non-Invasive Brain Stimulation with tDCS

Intervention Type DEVICE

20 minute tDCS intervention as a non-invasive neuromodulation treatment

Patients with TBI receiving group psychosocial intervention and the Categorization Program

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

Cognitive Intervention with the Categorization Program

Intervention Type BEHAVIORAL

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

Social Cognitive Communication Program

Intervention Type BEHAVIORAL

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

Interventions

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Cognitive Intervention with the Categorization Program

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

Intervention Type BEHAVIORAL

Social Cognitive Communication Program

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

Intervention Type BEHAVIORAL

Non-Invasive Brain Stimulation with tDCS

20 minute tDCS intervention as a non-invasive neuromodulation treatment

Intervention Type DEVICE

Other Intervention Names

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CP Soc Com tDCS Intervention

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cyprus

OTHER

Sponsor Role lead

Responsible Party

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Fofi Constantinidou

Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Cyprus

Nicosia, , Cyprus

Site Status

Countries

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Cyprus

Other Identifiers

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Excellence/0918/0117

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Excellence/1216/0411

Identifier Type: -

Identifier Source: org_study_id

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