Modeling Outcome in Patients With Acquired Brain Injuries

Brain Injuries Clinical Trial

— MOF-ABI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162091
• Other study ID #: CNR-IRIB-PRO-2023-007
• Status: Recruiting
• Start date: January 10, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2024
• Source: Istituto per la Ricerca e l'Innovazione Biomedica
• Contact: Antonio Cerasa
• Phone: +393339633511
• Email: antonio.cerasa[@]irib.cnr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Wounds and Injuries

Intervention

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: 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.

Locations

Country	Name	City	State
Italy	Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)	Messina

Sponsors (18)

Lead Sponsor

Collaborator

Istituto per la Ricerca e l'Innovazione Biomedica

Casa Sollievo della Sofferenza IRCCS, Centro Cardinal Ferrari, Fontanellato, Parma, Fondazione Don Carlo Gnocchi Onlus, 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

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glasgow Outcome Scale - Extended	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	Early Rehabilition Barthel Index	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.