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Clinical Trials in Italy / NCT07119827
Recruiting Observational

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

NCT07119827 · tracked via the Priya Life Science Italy tracker
Sponsor
Universita di Verona
Phase
Observational
Started
2025-05-01
Last updated
2026-07-02

Condition(s) studied

IctusSevere Acquired Brain InjurysABI

Investigational drug(s) / intervention(s)

Motor, cognitive and psychological assessment

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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Montreal Cognitive Assessment (MoCA) — 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.

Trial sites (1)

FacilityCityRegionStatus
Sezione medicina fisica e riabilitativa dipartimento di neuroscienze, verona Verona VR Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07119827 on ClinicalTrials.gov ↗ ← All trials in Italy