Modeling Outcome in Patients With Acquired Brain Injuries

Recruiting

• Conditions: Brain Injuries
• Interventions: Other: Data collection

• Registration Number: NCT06162091
• Lead Sponsor: Istituto per la Ricerca e l'Innovazione Biomedica

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-30
• Study First Submitted QC: 2023-11-30
• Study First Posted: 2023-12-08
• Study Start: 2024-01-10
• Primary Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-29
• Last Update Posted: 2025-05-01
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with severe acquired brain injuries	Data collection	Patients with severe acquired brain injuries admitted at intensive Rehabilitation Units for severe acquired brain injury within 3 months from occurrence

Primary Outcome Measures

Name	Time	Method
Glasgow Outcome Scale - Extended	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 Outcome Measures

Name	Time	Method
Early Rehabilition Barthel Index	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).

Trial Locations

Locations (1)

Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR); 🇮🇹 Messina, Italy