Modeling Outcome in Patients With Acquired Brain Injuries

NCT06162091 | Recruiting

• 1 other identifier: CNR-IRIB-PRO-2023-007
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

acquired brain injury; functional outcome; Modeling trajectories; mathematical models

Outcome Measures

Primary Outcomes (1)

• Glasgow Outcome Scale - Extended

  The Glasgow Outcome Scale - Extended (GOS-E) is a widely used outcome instrument to assess disability and recovery after brain injury. There are 8 categories in the scale: 1 - Dead, 2 - Vegetative State, 3 - Low Severe Disability, 4- Upper Severe Disability, 5- Low Moderate Disability, 6- Upper Moderate Disability, 7- Low Good Recovery and 8-Upper Good Recovery. The minimum score is 1 (dead) and the maximum score is 8 (upper good recovery).

  The test needs approximately 5 minutes to complete.

Secondary Outcomes (1)

• Early Rehabilition Barthel Index

  The test needs approximately 20 minutes to complete.

Study Arms (1)

Patients with severe acquired brain injuries

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

Other: Data collection

Interventions

Data collection OTHER

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.

Patients with severe acquired brain injuries

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe acquired brain injury, of traumatic and no traumatic etiology, within 3 months of the occurrence

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

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead
• Istituto S.Anna Crotone: collaborator
• IRCCS Centro Neurolesi Bonino Pulejo: collaborator
• Centro Cardinal Ferrari, Fontanellato, Parma: collaborator
• Fondazione Istituto G. Giglio, Cefalù (PA): collaborator
• Habilita Istituto di Neuroriabilitazione, Zingonia (BG): collaborator
• Casa Sollievo della Sofferenza IRCCS: collaborator
• IRCCS Istituto delle Scienze Neurologiche di Bologna: collaborator
• IRCCS Sacro Cuore Don Calabria di Negrar: collaborator
• Fondazione Salvatore Maugeri: collaborator
• Istituti Clinici Zucchi: collaborator
• Istituto Clinico Humanitas: collaborator
• Istituto Medicina Fisica E Riabilitazione Gervasutta, Udine: collaborator
• Montecatone Rehabilitation Institute S.p.A.: collaborator
• Ospedale Di Riabilitazione Fondazione Santa Lucia, Roma: collaborator
• Ospedale San Giovanni Battista, Foligno (PG): collaborator
• Ospedale Ss. Trinità Di Fossano, Cuneo: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator

Study Sites (1)

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Messina, 98164, Italy

RECRUITING

Related Publications (1)

• Panunzi S, Lucca LF, De Tanti A, Cava F, Romoli A, Formisano R, Scarponi F, Estraneo A, Frattini D, Tonin P, Piergentilli I, Pioggia G, De Gaetano A, Cerasa A. Modeling outcome trajectories in patients with acquired brain injury using a non-linear dynamic evolution approach. Sci Rep. 2023 Apr 18;13(1):6295. doi: 10.1038/s41598-023-33560-x.

  PMID: 37072538 BACKGROUND

MeSH Terms

Conditions

Brain Injuries

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Antonio Cerasa

  Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Cerasa

CONTACT

+393339633511; antonio.cerasa@irib.cnr.it

Maria Valeria Maiorana

CONTACT

mariavaleria.maiorana@irib.cnr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Head of Unit

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 8, 2023
• Study Start: January 10, 2024
• Primary Completion: December 31, 2024
• Study Completion: May 31, 2025
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)