IctusNCT07119827
Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury
An observational study of Ictus and Severe Acquired Brain Injury, run by Universita di Verona at 1 site in Italy.
Trial summary
This study aims to evaluate the potential effects of premorbid personality on the short- and long-term global cognitive recovery in patients with severe acquired brain injury (sABI) or stroke. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ictus, Severe Acquired Brain Injury, sABI
- What is being tested?
- Motor, cognitive and psychological assessment
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2025to 1 May 2028
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients admitted to the Neurorehabilitation Unit (UOC) of AOUI Verona (and collaborating centers) will be enrolled in this study.
Who may be able to join
- diagnosis of one of the following two conditions:
- Severe Acquired Brain Injury (sABI) of traumatic or non-traumatic etiology; the term sABI includes acute brain injuries of traumatic or non-traumatic origin (vascular, infectious, metabolic, or anoxic), in which the patient initially presents with a coma state (Glasgow Coma Scale - GCS less than 8) and simultaneously exhibits motor, sensory, cognitive, and/or behavioral impairments.
- Ischemic or hemorrhagic stroke without features of Severe Acquired Brain Injury (sABI) (Glasgow Coma Scale [GCS] score ≥ 8 and no alteration of consciousness).
- Time from injury between:
- 7 and 90 days for Severe Acquired Brain Injury (sABI) patients
- 3 and 30 days for stroke patients
Show all 9Show fewer
- Level of Cognitive Functioning (LCF) score ≥ 6 for sABI patients
- Signed informed consent for study participation
- Presence of a support family member (caregiver) able to assist with completing the personality questionnaire (HEXACO Adjective Scale, HAS)
Who cannot join
- Pre-existing neurological pathology
- Severe aphasia or severe inattention that precludes administration of the tests required by the protocol, as identified during cognitive screening.
- Patients with a language barrier due to insufficient proficiency in Italian.
- Particularly vulnerable populations:
- The following patients will be excluded from the study: patients in emergency situations.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Sezione medicina fisica e riabilitativa dipartimento di neuroscienze, verona
Verona, VR, 37135
Valentina Varalta, 0458124956 ext. 39, valentina.varalta@univr.it
About this study
Official title: Neuropsychology and Personality: Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury
This study aims to evaluate the potential effects of premorbid personality on the short- and long-term global cognitive recovery in patients with severe acquired brain injury (sABI) or stroke.
The secondary aims are to assess the effects of premorbid personality on the sort- and long-term recovery in autonomy (disability), cognitive functions, psycho-behavioral functioning, motor skills, and social participation. Evaluate the incidence of premorbid personality alterations. Investigate personality changes 12-18 months after the neurological event.
Read the detailed description
Participants included in the study will undergo cognitive, motor, psychological, behavioral, personality, and disability assessments at different time points following the neurological event:
T0: Initial assessment upon admission to the rehabilitation facility; within 90 days of the event for patients with severe acquired brain injury (sABI), as soon as cognitive evaluation becomes feasible (LCF ≥ 6); within 30 days of the event for stroke patients, as soon as cognitive assessment is possible.
T1: At discharge from the inpatient rehabilitation program, provided that at least 30 days have passed since the initial assessment (T0).
T2: At 12 months post-event for stroke patients and at 18 months post-event for patients with ABI.
- Conditions
- Ictus, Severe Acquired Brain Injury, sABI
- Being tested
- Motor, cognitive and psychological assessment
- Keywords
- premorbid personality, stroke, severe acquired brain injury, recovery, cognitive deficits, motor deficits, disability, psychological functioning, behaviour, sABI
- Medical subject headings
- Brain Injuries, Stroke, Cognition Disorders, Neurologic Manifestations, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor, cognitive and psychological assessmentDiagnostic test
Participants evaluated at T0 (Initial assessment upon admission to the rehabilitation facility), T1 (at discharge from the inpatient rehabilitation program, as long as at least 30 days have passed since the initial assessment (T0), T2 (at 12 months from the event for patients with stroke, and at 18 months from the event for patients with sABI).
| Study group | Role | What they receive |
|---|---|---|
| Ischemic or hemorrhagic stroke | Aged between 18 and 80 years; ischemic or hemorrhagic stroke without features of severe acquired brain injury (Glasgow Coma Scale ≥ 8 and no alteration in consciousness); time from onset between 3 and 30 days Receives: Diagnostic Test: Motor, cognitive and psychological assessment | |
| Severe Acquired Brain Injury (sABI) of traumatic or non-traumatic etiology | Aged between 18 and 80 years; severe Acquired Brain Injury (sABI) of traumatic or non-traumatic etiology meaning that the patient initially presents with a state of coma (Glasgow Coma Scale score < 8) accompanied by simultaneous motor, sensory, cognitive and/or behavioral impairment; Glasgow Coma Scale ≥ 8 and no alteration in consciousness; time from onset between 7 and 90 days; Level of Cognitive Functioning (LCF) >=6 Receives: Diagnostic Test: Motor, cognitive and psychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
MoCA is a brief, standardized screening tool designed to detect the global cognitive status of patients. It assesses multiple cognitive domains, including: Attention and concentration, Executive functions, Memory, Language, Visuoconstructional skills, Conceptual thinking, Calculations, Orientation. The test takes approximately 10 to 15 minutes to administer and yields a total score out of 30 points. Higher scores indicates a better performance. In the study it is used to evaluate the potential effects of premorbid personality on the degree of global cognitive rocovery in the short and long term.
Measured: The test is administered (both stroke and sABI) at baseline-T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).
Secondary outcomes (23)
Oxford Cognitive Screen (OCS)
Neuropsychological assessment tool that measures a person's global cognitive status, providing an analysis of key cognitive functions such as memory, executive functions, praxis, attention, language, and visuospatial exploration. Composed of various sub-tests, the OCS allows for the rapid and systematic identification of potential cognitive deficits and is particularly useful in patients with brain damage, such as those with stroke. Higher scores meaning a better performance.
Measured: The test is administered (both stroke and sABI) at baseline-T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).
Trial Making Test (TMT)
Consists of two parts: TMT-A, used as a measure of psychomotor speed and visual search/attention skills; TMT-B used as a measure of attentional set-shifting and mental flexibility. Time needed to complete the tasks is recorded.
Measured: The test is administered (both stroke and sABI) at baseline -T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).
Digit Span Forward
Digit Span Forward is a brief, standardized subtest used to assess attention and short-term verbal memory. It requires the patient to repeat a sequence of numbers in the same order as presented by the examiner, with increasing length. The task evaluates auditory attention, immediate recall, and working memory span. Higher scores indicate better performance. In the study, it is used to investigate the relationship between premorbid personality traits and specific cognitive functions, particularly attentional capacity.
Measured: The test is administered (both stroke and sABI at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).
Corsi Span Forward
Corsi Span Forward is a brief, standardized visuospatial memory task used to assess short-term visuospatial memory and attention. During the task, the examiner taps a sequence of blocks on a board, and the patient is required to reproduce the same sequence in the same order. The length of the sequence increases progressively. Higher scores indicate better visuospatial short-term memory performance. In the study, it is used to explore the association between premorbid personality traits and the recovery of visuospatial attention and memory functions.
Measured: The test is administered (both stroke and sABI)at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).
Digit Span Backward
Digit Span Backward is a standardized neuropsychological task that assesses working memory and attention. In this task, the examiner reads aloud a sequence of digits, and the patient is required to repeat them in reverse order. The sequence length increases progressively until the patient can no longer recall the digits correctly. Higher scores reflect better working memory performance. In the study, it is used to investigate the relationship between premorbid personality traits and recovery of working memory and attentional control.
Measured: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).
Corsi span backward
Corsi Span Backward is a standardized visuospatial memory task used to assess working memory and executive functions. In this task, the examiner taps a sequence of blocks on a board, and the patient is required to reproduce the sequence in reverse order. The sequences increase in length until the patient can no longer reproduce them correctly. Higher scores indicate better visuospatial working memory and manipulation abilities. In the study, it is used to examine how premorbid personality traits may influence the recovery of executive and visuospatial memory functions.
Measured: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).
Rey Auditory Verbal Learning Test (RAVLT)
The Rey Auditory Verbal Learning Test (RAVLT) is a standardized neuropsychological assessment of verbal learning and memory. The test involves the oral presentation of a list of 15 unrelated words over five learning trials, followed by immediate recall after each trial, an interference list, immediate recall of the original list, and delayed recall after a 20-30-minute interval. A recognition trial is also included. RAVLT. Higher scores indicate better verbal learning and memory abilities. In the study, it is used to assess how premorbid personality may influence short- and long-term verbal memory recovery.
Measured: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).
Test della Figura di Rey - Test della Figura di Taylor
The Rey-Osterrieth Complex Figure Test (ROCFT) and the Taylor Complex Figure Test (TCFT) are standardized neuropsychological tools used to assess visuospatial constructional abilities and non-verbal memory. Participants are asked to copy a complex figure (Rey or Taylor) and then reproduce it from memory after a short delay and again after a longer delay. The TCFT is used as an alternative version to minimize learning effects during repeated assessments. These tests evaluate multiple cognitive processes, including visuoperception, planning, attention, working memory, and long-term visuospatial memory. Higher scores reflect better performance. In the study, they are used to evaluate the influence of premorbid personality traits on visuospatial memory and planning skills in the short and long term.
Measured: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).
Stroop Test (ST)
Evaluates attention and the ability to inhibit automatic responses. The Stroop effect is evaluated by computing a time interference effect (based on execution time) and an error interference effect (based on number of errors).
Measured: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).
Modified Five Point Test (MFPT)
It measures figural fluency by assessing the ability to initiate mental productivity and self-monitoring during a visual-spatial task. Performance is assessed by scoring the total number of correct and unique designs generated in 3 min (UDs), and the total number of UDs produced into strategies (CSs).
Measured: The test is administered (both stroke and sABI) at baseline-T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).
Phonemic fluency
Phonemic Fluency is a brief verbal task assessing executive functions, especially lexical retrieval and cognitive flexibility. Participants must say as many words as possible beginning with a given letter in 60 seconds. Higher scores reflect better executive functioning. In the study, it assesses the potential impact of premorbid personality on verbal recovery.
Measured: The test is administered (only sABI) at baseline-T0 (between 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 ( 18 months from onset - sABI).
Semantic fluency
Semantic Fluency assesses verbal memory and executive functioning. Participants list as many words as possible from a semantic category (e.g., animals) in 60 seconds. Higher scores indicate better cognitive performance. In the study, it evaluates the influence of premorbid personality on language and executive recovery.
Measured: The test is administered (only sABI) at baseline-T0 (between 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 ( 18 months from onset - sABI).
Verbal Reasoning Test (VRT)
The Verbal Reasoning Test evaluates verbal reasoning skills through tasks such as identifying absurdities, intruders, relationships, differences, idiomatic expressions, familiarity, and classifications. Higher scores indicate stronger verbal reasoning. In the study, it assesses how premorbid personality influences verbal reasoning recovery.
Measured: Administered at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).
Brain Injury Rehabilitation Trust questionnaire (BIRT)
Both versions (for patient, for relatives). Self-report tools used to assess psycho-behavioral functioning in individuals with brain injury. It evaluates emotional, behavioral, and social aspects relevant to rehabilitation outcomes. Higher scores indicate greater difficulties. In the study, it is used to explore the impact of premorbid personality on psycho-behavioral recovery.
Measured: Administered (both sABI and stroke) at at follow-up T2 (12 months post-stroke; 18 months post-sABI).
Hospital Anxiety and Depression Scale (HADS)
Is a self-administered questionnaire designed to assess anxiety and depression symptoms in medically ill patients. It consists of 14 items divided equally between anxiety and depression subscales. Higher scores indicate greater symptom severity. In the study, it is used to evaluate the influence of premorbid personality on psychological well-being during recovery.
Measured: Administered (both stroke and sABI) at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).
HEXACO Adjective Scale (HAS)
Is a self-report personality questionnaire assessing six major personality dimensions: Honesty-Humility, Emotionality, Extraversion, Agreeableness, Conscientiousness, and Openness to Experience. It uses adjective-based items to capture trait levels. Higher scores reflect stronger expression of each trait. In the study, it is used to investigate the role of premorbid personality in cognitive and functional recovery.
Measured: Administered (both stroke an sABI) at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI) and at follow-up T2 (12 months post-stroke; 18 months post-sABI).
Disability Rating Scale (DRS)
Is a standardized tool used to assess the level of disability and functional changes in individuals with brain injury. It evaluates areas such as consciousness, cognitive ability for self-care, dependence on others, and employability. Scores range from no disability to extreme vegetative state, with higher scores indicating greater disability. In the study, it is used to measure functional recovery and independence over time.
Measured: Administered at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).
Frenchay Activities Index (FAI)
Is a questionnaire designed to assess the level of participation in instrumental activities of daily living (IADLs) following brain injury or stroke. It evaluates domestic chores, leisure, social activities, and work-related tasks. Higher scores indicate greater independence and activity participation. In the study, it is used to monitor social participation and functional recovery.
Measured: Administered (both stroke and sABI) at follow-up T2 (12 months post-stroke; 18 months post-sABI).
Fugl Mayer (FM)
Is a standardized scale used to evaluate motor functioning, balance, sensation, and joint functioning in post-stroke patients. It is widely used to assess recovery of motor impairment, particularly in the upper and lower extremities. Higher scores indicate better motor function. In the study, it is used to measure motor recovery over time.
Measured: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).
Motricity Index (MI)
Is a clinical scale used to assess motor strength in patients with neurological impairments, especially after stroke. It evaluates muscle power in the upper and lower limbs through specific movements. Higher scores indicate greater muscle strength and motor function. In the study, it is used to monitor motor recovery and functional status.
Measured: Administered (both stroke and sABI) at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).
Modified Ashworth Scale (MAS)
Is a clinical tool used to measure muscle spasticity in patients with neurological conditions such as stroke or brain injury. It assesses resistance during passive soft-tissue stretching and grades spasticity on a scale from 0 (no increase in muscle tone) to 4 (affected part rigid). Higher scores indicate greater spasticity. In the study, it is used to evaluate changes in muscle tone during motor recovery.
Measured: Administered (both stroke and sABI) at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).
Modified barthel Index (MBI)
Is a clinical scale used to measure a patient's level of independence in performing basic activities of daily living (ADLs), such as feeding, bathing, grooming, dressing, bowel and bladder control, mobility, and stair climbing. Higher scores indicating greater functional independence. In the study, it is used to assess disability levels and functional outcomes during rehabilitation.
Measured: Administered (only stroke) at baseline-T0 (3-30 days post-stroke), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; ).
Disability Rating Scale (DRS)
Is a clinical tool used to assess the overall level of disability in individuals recovering from severe brain injury, including traumatic and non-traumatic causes. It evaluates a range of functional areas, including consciousness, cognitive ability for self-care, level of dependence, and psychosocial adaptability. Scores range from 0 (no disability) to 29 (extreme vegetative state), with higher scores indicating greater disability. In the study, it is used to monitor functional recovery and global disability over time.
Measured: Administered (only sABI) at baseline-T0 (7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (18 months post-sABI).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 May 2025
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IctusStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda USL Toscana Sud Est, Centro Cardinal Ferrari, Fontanellato, Parma, Fondazione IRCCS Santa Lucia, Roma, Italy, Azienda Unita Sanitaria Locale di Piacenza, Azienda Sanitaria dell'Alto Adige, Azienda Ospedaliero, Universitaria Pisana, Azienda Sanitaria Locale CN1 Cuneo, Istituto S.Anna Crotone, Montecatone Rehabilitation Institute S.p.A., Imola (Italy), IRCCS Don Carlo Gnocchi di Firenze, IRCCS Don Carlo Gnocchi Milano, CRT Montevarchi Arezzo
- Responsible party
- Principal investigator, Valentina Varalta, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119827
- Sponsor's protocol ID
- 481CET
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuropsychology and Personality: Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT07119827
- Acronym / sponsor ID
- 481CET
- Conditions
- Ictus, Severe Acquired Brain Injury, sABI
- Keywords
- premorbid personality, stroke, severe acquired brain injury, recovery, cognitive deficits, motor deficits, disability, psychological functioning
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Collaborators
- Azienda USL Toscana Sud Est, Centro Cardinal Ferrari, Fontanellato, Parma, Fondazione IRCCS Santa Lucia, Roma, Italy, Azienda Unita Sanitaria Locale di Piacenza, Azienda Sanitaria dell'Alto Adige, Azienda Ospedaliero, Universitaria Pisana, Azienda Sanitaria Locale CN1 Cuneo, Istituto S.Anna Crotone, Montecatone Rehabilitation Institute S.p.A., Imola (Italy), IRCCS Don Carlo Gnocchi di Firenze, IRCCS Don Carlo Gnocchi Milano, CRT Montevarchi Arezzo
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 13 Aug 2025 (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.
This study aims to evaluate the potential effects of premorbid personality on the short- and long-term global cognitive recovery in patients with severe acquired brain injury (sABI) or stroke.
The secondary aims are to assess the effects of premorbid personality on the sort- and long-term recovery in autonomy (disability), cognitive functions, psycho-behavioral functioning, motor skills, and social participation. Evaluate the incidence of premorbid personality alterations. Investigate personality changes 12-18 months after the neurological event.
Detailed description
Participants included in the study will undergo cognitive, motor, psychological, behavioral, personality, and disability assessments at different time points following the neurological event:
T0: Initial assessment upon admission to the rehabilitation facility; within 90 days of the event for patients with severe acquired brain injury (sABI), as soon as cognitive evaluation becomes feasible (LCF ≥ 6); within 30 days of the event for stroke patients, as soon as cognitive assessment is possible.
T1: At discharge from the inpatient rehabilitation program, provided that at least 30 days have passed since the initial assessment (T0).
T2: At 12 months post-event for stroke patients and at 18 months post-event for patients with ABI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic or hemorrhagic stroke | – | Diagnostic Test: Motor, cognitive and psychological assessmentAged between 18 and 80 years; ischemic or hemorrhagic stroke without features of severe acquired brain injury (Glasgow Coma Scale ≥ 8 and no alteration in consciousness); time from onset between 3 and 30 days |
| Severe Acquired Brain Injury (sABI) of traumatic or non-traumatic etiology | – | Diagnostic Test: Motor, cognitive and psychological assessmentAged between 18 and 80 years; severe Acquired Brain Injury (sABI) of traumatic or non-traumatic etiology meaning that the patient initially presents with a state of coma (Glasgow Coma Scale score < 8) accompanied by simultaneous motor, sensory, cognitive and/or behavioral impairment; Glasgow Coma Scale ≥ 8 and no alteration in consciousness; time from onset between 7 and 90 days; Level of Cognitive Functioning (LCF) >=6 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients admitted to the Neurorehabilitation Unit (UOC) of AOUI Verona (and collaborating centers) will be enrolled in this study.
Key inclusion criteria (9 listed)
- diagnosis of one of the following two conditions:
- Severe Acquired Brain Injury (sABI) of traumatic or non-traumatic etiology; the term sABI includes acute brain injuries of traumatic or non-traumatic origin (vascular, infectious, metabolic, or anoxic), in which the patient initially presents with a coma state (Glasgow Coma Scale - GCS less than 8) and simultaneously exhibits motor, sensory, cognitive, and/or behavioral impairments.
- Ischemic or hemorrhagic stroke without features of Severe Acquired Brain Injury (sABI) (Glasgow Coma Scale [GCS] score ≥ 8 and no alteration of consciousness).
- Time from injury between:
- 7 and 90 days for Severe Acquired Brain Injury (sABI) patients
Key exclusion criteria (5 listed)
- Pre-existing neurological pathology
- Severe aphasia or severe inattention that precludes administration of the tests required by the protocol, as identified during cognitive screening.
- Patients with a language barrier due to insufficient proficiency in Italian.
- Particularly vulnerable populations:
- The following patients will be excluded from the study: patients in emergency situations.
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 |
|---|---|---|
| Motor, cognitive and psychological assessmentParticipants evaluated at T0 (Initial assessment upon admission to the rehabilitation facility), T1 (at discharge from the inpatient rehabilitation program, as long as at least 30 days have passed since the initial assessment (T0), T2 (at 12 months from the event for patients with stroke, and at 18 months from the event for patients with sABI). | Diagnostic test | Ischemic or hemorrhagic stroke, Severe Acquired Brain Injury (sABI) of traumatic or non-traumatic etiology |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: The test is administered (both stroke and sABI) at baseline-T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).
MoCA is a brief, standardized screening tool designed to detect the global cognitive status of patients. It assesses multiple cognitive domains, including: Attention and concentration, Executive functions, Memory, Language, Visuoconstructional skills, Conceptual thinking, Calculations, Orientation. The test takes approximately 10 to 15 minutes to administer and yields a total score out of 30 points. Higher scores indicates a better performance. In the study it is used to evaluate the potential effects of premorbid personality on the degree of global cognitive rocovery in the short and long term.
23 secondary outcomes
Oxford Cognitive Screen (OCS)
Time frame: The test is administered (both stroke and sABI) at baseline-T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).
Trial Making Test (TMT)
Time frame: The test is administered (both stroke and sABI) at baseline -T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).
Digit Span Forward
Time frame: The test is administered (both stroke and sABI at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).
Corsi Span Forward
Time frame: The test is administered (both stroke and sABI)at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).
Digit Span Backward
Time frame: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).
Corsi span backward
Time frame: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).
Test della Figura di Rey - Test della Figura di Taylor
Time frame: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).
Stroop Test (ST)
Time frame: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).
Modified Five Point Test (MFPT)
Time frame: The test is administered (both stroke and sABI) at baseline-T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).
Phonemic fluency
Time frame: The test is administered (only sABI) at baseline-T0 (between 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 ( 18 months from onset - sABI).
Semantic fluency
Time frame: The test is administered (only sABI) at baseline-T0 (between 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 ( 18 months from onset - sABI).
Verbal Reasoning Test (VRT)
Time frame: Administered at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).
Brain Injury Rehabilitation Trust questionnaire (BIRT)
Time frame: Administered (both sABI and stroke) at at follow-up T2 (12 months post-stroke; 18 months post-sABI).
Hospital Anxiety and Depression Scale (HADS)
Time frame: Administered (both stroke and sABI) at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).
HEXACO Adjective Scale (HAS)
Time frame: Administered (both stroke an sABI) at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI) and at follow-up T2 (12 months post-stroke; 18 months post-sABI).
Disability Rating Scale (DRS)
Time frame: Administered at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).
Frenchay Activities Index (FAI)
Time frame: Administered (both stroke and sABI) at follow-up T2 (12 months post-stroke; 18 months post-sABI).
Fugl Mayer (FM)
Time frame: The test is administered both stroke and sABI, at baseline-T0 (between 3-30 days from onset - stroke; 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 (12 months from onset - stroke; 18 months from onset - sABI).
Motricity Index (MI)
Time frame: Administered (both stroke and sABI) at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).
Modified Ashworth Scale (MAS)
Time frame: Administered (both stroke and sABI) at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).
Modified barthel Index (MBI)
Time frame: Administered (only stroke) at baseline-T0 (3-30 days post-stroke), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; ).
Disability Rating Scale (DRS)
Time frame: Administered (only sABI) at baseline-T0 (7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (18 months post-sABI).
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 2 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 Ictus and Severe Acquired Brain Injury, run by Universita di Verona 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 9 inclusion and 5 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 2 Jul 2026. 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 Valentina Varalta (0458124956 ext. 39, valentina.varalta@univr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: The test is administered (both stroke and sABI) at baseline-T0 (between 3-30 days from onset - ictus; 7-90 days from onset - sABI), at discharge (at least 30 days from T0) and at followup-T2 (12 moths from onset - ictus; 18 months from onset - sABI).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jul 2026.