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Recruiting NCT06162091

Modeling Outcome in Patients With Acquired Brain Injuries

— Observational Brain Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Data collection.
Who it may be relevant to
Registry conditions: Brain Injuries. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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 coll

Primary outcome measures

  • Glasgow Outcome Scale - Extended [Time frame: The test needs approximately 5 minutes to complete.]
Secondary outcome measures (1)
  • Early Rehabilition Barthel Index [Time frame: The test needs approximately 20 minutes to complete.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR) — Messina

Publications

  • 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

Identifiers

NCT: NCT06162091 · CNR-IRIB-PRO-2023-007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗