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

April 29, 2025 updated by: Antonio Cerasa, Istituto per la Ricerca e l'Innovazione Biomedica

Modeling Trajectories of Functional Outcome in Patients With Severe Acquired Brain Injuries Using a Non-Linear Dynamic Evolution Approach.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Messina, Italy, 98164
        • Recruiting
        • Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonio Cerasa
        • Sub-Investigator:
          • Lucia Francesca Lucca
        • Sub-Investigator:
          • Rocco Salvatore Calabrò
        • Sub-Investigator:
          • Andrea De Gaetano
        • Sub-Investigator:
          • Simona Panunzi
        • Sub-Investigator:
          • Paolo Tonin
        • Sub-Investigator:
          • Antonino Principato
        • Sub-Investigator:
          • Elena Antoniono
        • Sub-Investigator:
          • Sergio Bagnato
        • Sub-Investigator:
          • Hakiki Bahia
        • Sub-Investigator:
          • Michelangelo Bartolo
        • Sub-Investigator:
          • Alberto Battistini
        • Sub-Investigator:
          • Laura Cecotti
        • Sub-Investigator:
          • Silvia Ciotti
        • Sub-Investigator:
          • Valentina Colombo
        • Sub-Investigator:
          • Annalisa Coppo
        • Sub-Investigator:
          • Carla Corsini
        • Sub-Investigator:
          • Antonio De Tanti
        • Sub-Investigator:
          • Anna Estraneo
        • Sub-Investigator:
          • Rita Formisano
        • Sub-Investigator:
          • Francesca Gozzerino
        • Sub-Investigator:
          • Domenico Intiso
        • Sub-Investigator:
          • Fabio La Porta
        • Sub-Investigator:
          • Alfonso Magliacano
        • Sub-Investigator:
          • Alessandro Michelutti
        • Sub-Investigator:
          • Cecilia Perin
        • Sub-Investigator:
          • Vincenzo Provitera
        • Sub-Investigator:
          • Annamaria Romoli
        • Sub-Investigator:
          • Elena Rossato
        • Sub-Investigator:
          • Pamela Salucci
        • Sub-Investigator:
          • Federico Scarponi
        • Sub-Investigator:
          • Maria Valeria Maiorana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glasgow Outcome Scale - Extended
Time Frame: The test needs approximately 5 minutes to complete.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early Rehabilition Barthel Index
Time Frame: The test needs approximately 20 minutes to complete.

The Early Rehabilition Barthel Index (ERBI) is usually used to measure functional changes in patients with severe acquired brain injury.

ERBI consists of 17 items grouped into two sections, A and B. Section A consists of six "negative" items that can be given the scores - 50 and 0, and one item with scores -25 and 0.

Section B corresponds to the original Barthel Index, with ten "positive" items, with three scores: 0, 5 and 10.

The total from section A ranges from - 325 to 0 points, the total from section B from 0 to l00. Therefore, the final total, given by A + B, ranges from -325 (the worst) to +l 00 (the best).
The test needs approximately 20 minutes to complete.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Collaborators

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

Investigators

  • Principal Investigator: Antonio Cerasa, Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 8, 2023

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNR-IRIB-PRO-2023-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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