Modeling Outcome in Patients With Acquired Brain Injuries

Summary

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.

Conditions

• Brain Injuries

Interventions

OTHER

Data collection

The study will involve at the time of entry into the rehabilitation setting, the collection of data related to demographic and clinical variables assessing: 1. The Level of responsiveness (Coma Recovery Scale -revised (CRS-r); 2. Cognitive functioning (Levels of Cognitive Functioning, LCF); 3. disability (Disability Rating Scale, DRS); 4. level of care needed (Early Rehabilition Barthel Index, ERBI) The Final outcome measure will be the Glasgow Outcome Scale- Extended (GOSE). It will also collect data on clinical variables and presence of medical devices (e.g. decompressive craniectomy, hydrocephalus, tracheostomy, respiration). For all evaluations, two monthly timepoints will be conducted for a total of 12 timepoints until discharge (0 -6 months). If the patient will be hospitalized for more than 6 months, the assessment will be done monthly up to 12 months.

Sponsors & Collaborators

• Istituto S.Anna Crotone

  collaborator UNKNOWN

• IRCCS Centro Neurolesi Bonino Pulejo

  collaborator OTHER

• Centro Cardinal Ferrari, Fontanellato, Parma

  collaborator UNKNOWN

• Fondazione Istituto G. Giglio, Cefalù (PA)

  collaborator UNKNOWN

• Habilita Istituto di Neuroriabilitazione, Zingonia (BG)

  collaborator UNKNOWN

• Casa Sollievo della Sofferenza IRCCS

  collaborator OTHER

• IRCCS Istituto delle Scienze Neurologiche di Bologna

  collaborator OTHER

• IRCCS Sacro Cuore Don Calabria di Negrar

  collaborator OTHER

• Fondazione Salvatore Maugeri

  collaborator OTHER

• Istituti Clinici Zucchi

  collaborator OTHER

• Istituto Clinico Humanitas

  collaborator OTHER

• Istituto Medicina Fisica E Riabilitazione Gervasutta, Udine

  collaborator UNKNOWN

• Montecatone Rehabilitation Institute S.p.A.

  collaborator OTHER

• Ospedale Di Riabilitazione Fondazione Santa Lucia, Roma

  collaborator UNKNOWN

• Ospedale San Giovanni Battista, Foligno (PG)

  collaborator UNKNOWN

• Ospedale Ss. Trinità Di Fossano, Cuneo

  collaborator UNKNOWN

• Fondazione Don Carlo Gnocchi Onlus

  collaborator OTHER

• Istituto per la Ricerca e l'Innovazione Biomedica

  lead OTHER

Principal Investigators

• Antonio Cerasa · Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-01-10

Primary Completion

2024-12-31

Completion

2025-05-31

Countries

• Italy

Study Locations