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NCT Number: NCT06162091

Modeling Outcome in Patients With Acquired Brain Injuries

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Messina, 98164, Italy

Location status: Recruiting

Location contact

Alberto Battistini

SUB_INVESTIGATOR

Alessandro Michelutti

SUB_INVESTIGATOR

Alfonso Magliacano

SUB_INVESTIGATOR

Andrea De Gaetano

SUB_INVESTIGATOR

Anna Estraneo

SUB_INVESTIGATOR

Annalisa Coppo

SUB_INVESTIGATOR

Annamaria Romoli

SUB_INVESTIGATOR

Antonino Principato

SUB_INVESTIGATOR

Antonio Cerasa

CONTACT

[email protected]

Antonio Cerasa

PRINCIPAL_INVESTIGATOR

Antonio De Tanti

SUB_INVESTIGATOR

Carla Corsini

SUB_INVESTIGATOR

Cecilia Perin

SUB_INVESTIGATOR

Domenico Intiso

SUB_INVESTIGATOR

Elena Antoniono

SUB_INVESTIGATOR

Elena Rossato

SUB_INVESTIGATOR

Fabio La Porta

SUB_INVESTIGATOR

Federico Scarponi

SUB_INVESTIGATOR

Francesca Gozzerino

SUB_INVESTIGATOR

Hakiki Bahia

SUB_INVESTIGATOR

Laura Cecotti

SUB_INVESTIGATOR

Lucia Francesca Lucca

SUB_INVESTIGATOR

Maria Valeria Maiorana

CONTACT

[email protected]

Maria Valeria Maiorana

SUB_INVESTIGATOR

Michelangelo Bartolo

SUB_INVESTIGATOR

Pamela Salucci

SUB_INVESTIGATOR

Paolo Tonin

SUB_INVESTIGATOR

Rita Formisano

SUB_INVESTIGATOR

Rocco Salvatore Calabrò

SUB_INVESTIGATOR

Sergio Bagnato

SUB_INVESTIGATOR

Silvia Ciotti

SUB_INVESTIGATOR

Simona Panunzi

SUB_INVESTIGATOR

Valentina Colombo

SUB_INVESTIGATOR

Vincenzo Provitera

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • The Level of responsiveness (Coma Recovery Scale -revised (CRS-r);
  • Cognitive functioning (Levels of Cognitive Functioning, LCF);
  • disability (Disability Rating Scale, DRS);
  • 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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Cerasa

CONTACT

[email protected]

+393339633511

Maria Valeria Maiorana

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Istituto per la Ricerca e l'Innovazione Biomedica

Other

Collaborators

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

Registry information

Official study title

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

Acronym: MOF-ABI

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 8, 2023
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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