Brain InjuriesMOF-ABINCT06162091
Modeling Outcome in Patients With Acquired Brain Injuries
An observational study of Brain Injuries, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Data collection
- How many people
- 190 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2024to 31 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe acquired brain injury, of traumatic and no traumatic etiology, within 3 months of the occurrence
Who may be able to join
- 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
Who cannot join
- Positive remote medical history of pre-existing disabling neurological or orthopedic conditions and psychiatric disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Valeria Maiorana contact
Italy1 site, 1 recruiting
- Recruiting
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Messina, 98164
Antonio Cerasa, antonio.cerasa@irib.cnr.it
Maria Valeria Maiorana, mariavaleria.maiorana@irib.cnr.it
About this study
Official title: Modeling Trajectories of Functional Outcome in Patients With Severe Acquired Brain Injuries Using a Non-Linear Dynamic Evolution Approach.
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.
Read more
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.
- Conditions
- Brain Injuries
- Being tested
- Data collection
- Keywords
- acquired brain injury, functional outcome, Modeling trajectories, mathematical models
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with severe acquired brain injuries | Patients with severe acquired brain injuries admitted at intensive Rehabilitation Units for severe acquired brain injury within 3 months from occurrence Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The test needs approximately 5 minutes to complete.
Secondary outcomes (1)
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).
Measured: The test needs approximately 20 minutes to complete.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start10 Jan 2024
- Primary completion31 Dec 2024
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione Biomedica
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto S.Anna Crotone, IRCCS Centro Neurolesi Bonino Pulejo, Centro Cardinal Ferrari, Fontanellato, Parma, Fondazione Istituto G. Giglio, Cefalù (PA), Habilita Istituto di Neuroriabilitazione, Zingonia (BG), Casa Sollievo della Sofferenza IRCCS, IRCCS Istituto delle Scienze Neurologiche di Bologna, IRCCS Sacro Cuore Don Calabria di Negrar, Fondazione Salvatore Maugeri, Istituti Clinici Zucchi, Istituto Clinico Humanitas, Istituto Medicina Fisica E Riabilitazione Gervasutta, Udine, 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, Fondazione Don Carlo Gnocchi ETS
- Responsible party
- Principal investigator, Antonio Cerasa, Istituto per la Ricerca e l'Innovazione Biomedica
- Investigators
- Antonio Cerasa, Principal investigator, Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162091
- Sponsor's protocol ID
- CNR-IRIB-PRO-2023-007
- Acronym
- MOF-ABI
- Status last verified
- Apr 2025
- First submitted
- 30 Nov 2023
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 37072538
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling Trajectories of Functional Outcome in Patients With Severe Acquired Brain Injuries Using a Non-Linear Dynamic Evolution Approach.
- ClinicalTrials.gov ID
- NCT06162091
- Acronym / sponsor ID
- MOF-ABI / CNR-IRIB-PRO-2023-007
- Conditions
- Brain Injuries
- Keywords
- acquired brain injury, functional outcome, Modeling trajectories, mathematical models
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Istituto per la Ricerca e l'Innovazione BiomedicaUniversity, hospital or other
- Collaborators
- Istituto S.Anna Crotone, IRCCS Centro Neurolesi Bonino Pulejo, Centro Cardinal Ferrari, Fontanellato, Parma, Fondazione Istituto G. Giglio, Cefalù (PA), Habilita Istituto di Neuroriabilitazione, Zingonia (BG), Casa Sollievo della Sofferenza IRCCS, IRCCS Istituto delle Scienze Neurologiche di Bologna, IRCCS Sacro Cuore Don Calabria di Negrar, Fondazione Salvatore Maugeri, Istituti Clinici Zucchi, Istituto Clinico Humanitas, Istituto Medicina Fisica E Riabilitazione Gervasutta, Udine, 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, Fondazione Don Carlo Gnocchi ETS
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with severe acquired brain injuries | – | Other: Data collectionPatients with severe acquired brain injuries admitted at intensive Rehabilitation Units for severe acquired brain injury within 3 months from occurrence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe acquired brain injury, of traumatic and no traumatic etiology, within 3 months of the occurrence
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Positive remote medical history of pre-existing disabling neurological or orthopedic conditions and psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionThe 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 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. | Other | Patients with severe acquired brain injuries |
Primary outcome
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).
1 secondary outcome
Early Rehabilition Barthel Index
Time frame: The test needs approximately 20 minutes to complete.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Background: PubMed 37072538Panunzi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Valeria Maiorana contact
Antonio Cerasa principal investigator
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, run by Istituto per la Ricerca e l'Innovazione Biomedica at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Cerasa (+393339633511, antonio.cerasa@irib.cnr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale - Extended (time frame: The test needs approximately 5 minutes to complete.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06162091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.