Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury

NCT07119827 | Recruiting

• 1 other identifier: 481CET
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ictus; Severe Acquired Brain Injury; sABI

Keywords

premorbid personality; stroke; severe acquired brain injury; recovery; cognitive deficits; motor deficits; disability; psychological functioning; behaviour; sABI

Outcome Measures

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.

  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)

  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)

  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

  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

  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

  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).

Study Arms (2)

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

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

Diagnostic Test: Motor, cognitive and psychological assessment

Interventions

Motor, cognitive and psychological assessment DIAGNOSTIC_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).

Ischemic or hemorrhagic stroke; Severe Acquired Brain Injury (sABI) of traumatic or non-traumatic etiology

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients admitted to the Neurorehabilitation Unit (UOC) of AOUI Verona (and collaborating centers) will be enrolled in this study.

You may qualify if:

• 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:
• and 90 days for Severe Acquired Brain Injury (sABI) patients
• and 30 days for stroke patients
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universita di Verona: lead
• CRT Montevarchi (Arezzo), Dr. Benedetta Basagni: collaborator
• Azienda USL Toscana Sud Est: collaborator
• Centro Cardinal Ferrari, Fontanellato, Parma: collaborator
• Montecatone Rehabilitation Institute S.p.A., Imola (Italy): collaborator
• Fondazione IRCCS Santa Lucia, Roma, Italy: collaborator
• IRCCS Fondazione Don Carlo Gnocchi, Milano: collaborator
• Azienda Unita Sanitaria Locale di Piacenza, Italy: collaborator
• Azienda Sanitaria dell'Alto Adige: collaborator
• Azienda Ospedaliero, Universitaria Pisana: collaborator
• Azienda Sanitaria Locale CN1 Cuneo: collaborator
• Istituto S.Anna Crotone: collaborator
• Dr. Navarro Solano Jorghe, MD of the Fondazione Don Carlo Gnocchi Onlus Santa Maria Nascente center: collaborator
• Dr. Pasqualone Eugenia MD Fondazione Don Carlo Gnocchi Onlus of La Spezia center: collaborator
• SO Riabilitazione Neuromotoria, IRCCS Fondazione Don Carlo Gnocchi (Firenze) - Francesca Cecchi: collaborator
• SO Riabilitazione GCA, IRCCS Fondazione Don Carlo Gnocchi (Firenze) - Bahia Hakiki: collaborator

Study Sites (1)

Sezione medicina fisica e riabilitativa dipartimento di neuroscienze, verona

Verona, VR, 37135, Italy

RECRUITING

MeSH Terms

Conditions

Brain Injuries; Stroke; Cognition Disorders; Neurologic Manifestations; Behavior

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Valentina Varalta

CONTACT

0458124956; valentina.varalta@univr.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 13, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

IT (1)