Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversita di Verona
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
7 and 90 days for Severe Acquired Brain Injury (sABI) patients
3 and 30 days for stroke patients
Disqualifiers
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.
Trial population
Consecutive patients admitted to the Neurorehabilitation Unit (UOC) of AOUI Verona (and collaborating centers) will be enrolled in this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Motor, cognitive and psychological assessment
Diagnostic testParticipants 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).
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Ischemic or hemorrhagic stroke1 intervention
Group B: Severe Acquired Brain Injury (sABI) of traumatic or non-traumatic etiology1 intervention
Trial outcomes
Primary outcomes
1
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.
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).Secondary outcomes
1
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.
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).2
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.
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).3
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.
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).4
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.
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universita di Verona
Lead sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Sponsor institution
Azienda USL Toscana Sud Est
Collaborator
Centro Cardinal Ferrari, Fontanellato, Parma
Collaborator
Fondazione IRCCS Santa Lucia, Roma, Italy
Collaborator
Azienda Unita Sanitaria Locale di Piacenza
Collaborator
Azienda Sanitaria dell'Alto Adige
Collaborator
Azienda Ospedaliero, Universitaria Pisana
Collaborator
Azienda Sanitaria Locale CN1 Cuneo
Collaborator
Istituto S.Anna Crotone
Collaborator
Montecatone Rehabilitation Institute S.p.A., Imola (Italy)
Collaborator
IRCCS Don Carlo Gnocchi di Firenze
Collaborator
IRCCS Don Carlo Gnocchi Milano
Collaborator
CRT Montevarchi Arezzo
Collaborator
Source ClinicalTrials.gov