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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2028-05-01

Brief Summary

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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.

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Detailed Description

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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

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Ictus Severe Acquired Brain Injury sABI

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Motor, cognitive and psychological assessment

Intervention Type 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).

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

Motor, cognitive and psychological assessment

Intervention Type 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).

Interventions

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Motor, cognitive and psychological assessment

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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No