Modeling Outcome in Patients With Acquired Brain Injuries

Recruiting now

Conditions studied: Brain Injuries

In brief

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.

Key facts

Study ID: NCT06162091
Run by: Istituto per la Ricerca e l'Innovazione Biomedica
People needed: 190
Starts: 2024-01-10
Expected to finish: 2025-05-31
Last updated by the study team: 2025-05-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) — Messina, Italy (enrolling)

Full record on ClinicalTrials.gov

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