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

University of Verona

Status: Enrolling

Conditions: Ictus; sABI; Severe Acquired Brain Injury

Treatments: Diagnostic Test: Motor, cognitive and psychological assessment

Study type: Observational

Funder types: Other

Identifiers

NCT07119827

481CET

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• 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)

Exclusion criteria

• 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 design

250 participants in 2 patient groups

Ischemic or hemorrhagic stroke

Description:

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

Treatment:

Diagnostic Test: Motor, cognitive and psychological assessment

Severe Acquired Brain Injury (sABI) of traumatic or non-traumatic etiology

Description:

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

Treatment:

Diagnostic Test: Motor, cognitive and psychological assessment