Modeling Outcome in Patients With Acquired Brain Injuries (MOF-ABI)

Istituto per la Ricerca e l'Innovazione Biomedica

Status: Enrolling

Conditions: Brain Injuries

Treatments: Other: Data collection

Study type: Observational

Funder types: Other

Identifiers

NCT06162091

CNR-IRIB-PRO-2023-007

Details and patient eligibility

About

Acquired brain injury (ABI) is the leading cause of death and disability worldwide. The degree of severity varies according to a combination of numerous demographics, etiological, clinical, cognitive, behavioral, psychosocial and environmental factors, which can interfere with the effectiveness of rehabilitation interventions and, therefore, with the final outcome.

The most important goal of the modern clinic is to predict in time the progression of possible recovery after the brain injury event in order to provide more effective treatment, but the high heterogeneity and clinical variability and the unpredictability of the onset of comorbidities makes this a hard target to reach.

In recent years, artificial intelligence algorithms have been applied to more precisely define the role of critical variables that can help clinical practice to predict the final outcome. The classical approach of these algorithms provides only probabilistic values on the final outcome, without considering the typology of clinical interventions and overall complications that may appear throughout the hospitalization period.

The objective of this multicentric study is to define a new statistical approach that can describe the dynamics of individual clinical changes occuring during the inpatient intensive rehabilitation care period. The proposed approach combines a principal component analysis (PCA) for dimension reduction (capturing the maximum amount of information and reducing the dimensionality problem) and a nonlinear mathematical modeling for describing the evolution of the clinical course in terms of the resulting new PCA dimensions. By using this approach, we may determine the individual patient's temporal trajectories while examining particular clinical factors. The secondary objective of this study is to validate a new version of the Early Rehabilitation Barthel Index (ERBI), a well-known clinical scale used to measure functional changes in patients with severe acquired brain injury.

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with clinical diagnosis of severe acquired brain injury of different etiology (traumatic, hemorrhagic vascular,ischemic vascular, anoxic, infectious, other etiology
• interval since the acute occurrence that led to the clinical condition of ≤3 months duration
• age of 18 years or older
• informed consent signed by family member/caregiver/supporting caregiver

Exclusion criteria

• Positive remote medical history of pre-existing disabling neurological or orthopedic conditions and psychiatric disorders

Trial design

190 participants in 1 patient group

Patients with severe acquired brain injuries

Description:

Patients with severe acquired brain injuries admitted at intensive Rehabilitation Units for severe acquired brain injury within 3 months from occurrence

Treatment:

Other: Data collection