---
title: Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury
nct_id: NCT07119827
overall_status: RECRUITING
sponsor: Universita di Verona
study_type: OBSERVATIONAL
primary_condition: Ictus
countries: Italy
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07119827.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07119827"
ct_last_update_post_date: 2025-08-13
last_seen_at: "2026-05-12T06:16:52.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury

**Official Title:** Neuropsychology and Personality: Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury

**NCT ID:** [NCT07119827](https://clinicaltrials.gov/study/NCT07119827)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 250
- **Lead Sponsor:** Universita di Verona
- **Collaborators:** CRT Montevarchi (Arezzo), Dr. Benedetta Basagni, Azienda USL Toscana Sud Est, Centro Cardinal Ferrari, Fontanellato, Parma, Montecatone Rehabilitation Institute S.p.A., Imola (Italy), Fondazione IRCCS Santa Lucia, Roma, Italy, IRCCS Fondazione Don Carlo Gnocchi, Milano, Azienda Unita Sanitaria Locale di Piacenza, Azienda Sanitaria dell'Alto Adige, Azienda Ospedaliero, Universitaria Pisana, Azienda Sanitaria Locale CN1 Cuneo, Istituto S.Anna Crotone, Dr. Navarro Solano Jorghe, MD of the Fondazione Don Carlo Gnocchi Onlus Santa Maria Nascente center, Dr. Pasqualone Eugenia MD Fondazione Don Carlo Gnocchi Onlus of La Spezia center, SO Riabilitazione Neuromotoria, IRCCS Fondazione Don Carlo Gnocchi (Firenze) - Francesca Cecchi, SO Riabilitazione GCA, IRCCS Fondazione Don Carlo Gnocchi (Firenze) - Bahia Hakiki
- **Conditions:** Ictus, Severe Acquired Brain Injury, sABI
- **Start Date:** 2025-05-01
- **Completion Date:** 2028-05-01
- **CT.gov Last Update:** 2025-08-13

## 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.

## Detailed 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **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.
```

## Arms

- **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
- **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

## 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).

## Primary Outcomes

- **Montreal Cognitive Assessment (MoCA)** _(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).)_ — 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.

## Secondary Outcomes

- **Oxford Cognitive Screen (OCS)** _(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).)_
- **Trial Making Test (TMT)** _(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).)_
- **Digit Span Forward** _(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).)_
- **Corsi Span Forward** _(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).)_
- **Digit Span Backward** _(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).)_
- **Corsi span backward** _(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).)_
- **Rey Auditory Verbal Learning Test (RAVLT)** _(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).)_
- **Test della Figura di Rey - Test della Figura di Taylor** _(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).)_
- **Stroop Test (ST)** _(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).)_
- **Modified Five Point Test (MFPT)** _(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).)_
- **Phonemic fluency** _(time frame: The test is administered (only sABI) at baseline-T0 (between 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 ( 18 months from onset - sABI).)_
- **Semantic fluency** _(time frame: The test is administered (only sABI) at baseline-T0 (between 7-90 days from onset - sABI), at discharge (at least 30 days from T0), and at follow-up T2 ( 18 months from onset - sABI).)_
- **Verbal Reasoning Test (VRT)** _(time frame: Administered at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).)_
- **Brain Injury Rehabilitation Trust questionnaire (BIRT)** _(time frame: Administered (both sABI and stroke) at at follow-up T2 (12 months post-stroke; 18 months post-sABI).)_
- **Hospital Anxiety and Depression Scale (HADS)** _(time frame: Administered (both stroke and sABI) at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).)_
- **HEXACO Adjective Scale (HAS)** _(time frame: Administered (both stroke an sABI) at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI) and at follow-up T2 (12 months post-stroke; 18 months post-sABI).)_
- **Disability Rating Scale (DRS)** _(time frame: Administered at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).)_
- **Frenchay Activities Index (FAI)** _(time frame: Administered (both stroke and sABI) at follow-up T2 (12 months post-stroke; 18 months post-sABI).)_
- **Fugl Mayer (FM)** _(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).)_
- **Motricity Index (MI)** _(time frame: Administered (both stroke and sABI) at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).)_
- **Modified Ashworth Scale (MAS)** _(time frame: Administered (both stroke and sABI) at baseline-T0 (3-30 days post-stroke; 7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; 18 months post-sABI).)_
- **Modified barthel Index (MBI)** _(time frame: Administered (only stroke) at baseline-T0 (3-30 days post-stroke), at discharge (≥30 days from T0), and at follow-up T2 (12 months post-stroke; ).)_
- **Disability Rating Scale (DRS)** _(time frame: Administered (only sABI) at baseline-T0 (7-90 days post-sABI), at discharge (≥30 days from T0), and at follow-up T2 (18 months post-sABI).)_

## Locations (1)

- Sezione medicina fisica e riabilitativa dipartimento di neuroscienze, verona, Verona, VR, Italy — _RECRUITING_

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sezione medicina fisica e riabilitativa dipartimento di neuroscienze, verona|verona|vr|italy` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07119827.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07119827*  
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