Clinical trial NCT06162091: Modeling Outcome in Patients With Acquired Brain Injuries
Official title: Modeling Trajectories of Functional Outcome in Patients With Severe Acquired Brain Injuries Using a Non-Linear Dynamic Evolution Approach.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Injuries
Keywords: acquired brain injury
functional outcome
Modeling trajectories
mathematical models
Lead sponsor: Istituto per la Ricerca e l'Innovazione Biomedica
Sponsor class: OTHER
Collaborators: name: Istituto S.Anna Crotone
name: IRCCS Centro Neurolesi Bonino Pulejo
name: Centro Cardinal Ferrari, Fontanellato, Parma
name: Fondazione Istituto G. Giglio, Cefalù (PA)
name: Habilita Istituto di Neuroriabilitazione, Zingonia (BG)
name: Casa Sollievo della Sofferenza IRCCS
name: IRCCS Istituto delle Scienze Neurologiche di Bologna
name: IRCCS Sacro Cuore Don Calabria di Negrar
name: Fondazione Salvatore Maugeri
name: Istituti Clinici Zucchi
name: Istituto Clinico Humanitas
name: Istituto Medicina Fisica E Riabilitazione Gervasutta, Udine
name: Montecatone Rehabilitation Institute S.p.A.
name: Ospedale Di Riabilitazione Fondazione Santa Lucia, Roma
name: Ospedale San Giovanni Battista, Foligno (PG)
name: Ospedale Ss. Trinità Di Fossano, Cuneo
name: Fondazione Don Carlo Gnocchi Onlus
First posted: 2023-12-08
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe acquired brain injury, of traumatic and no traumatic etiology, within 3 months of the occurrence

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.


Eligibility criteria: 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

Primary outcomes:
measure: Glasgow Outcome Scale - Extended
timeFrame: The test needs approximately 5 minutes to complete.
Secondary outcomes:
measure: Early Rehabilition Barthel Index
timeFrame: The test needs approximately 20 minutes to complete.
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Study officials:
affiliation: Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
name: Antonio Cerasa
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.