Neuropsychology and Personality: Personality Traits as a Variable in the Recovery of Patients With Acquired Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Motor, cognitive and psychological assessment (Diagnostic Test)
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
干预措施: Motor, cognitive and psychological assessment (Diagnostic Test)
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: 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.
次要结局
- Disability Rating Scale (DRS)(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).)
- Modified Five Point Test (MFPT)(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).)
- 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 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).)
- Phonemic fluency(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).)
- Corsi 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).)
- Rey Auditory Verbal Learning Test (RAVLT)(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(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)(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).)
- Brain Injury Rehabilitation Trust questionnaire (BIRT)(Administered (both sABI and stroke) at at follow-up T2 (12 months post-stroke; 18 months post-sABI).)
- Semantic fluency(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)(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).)
- Hospital Anxiety and Depression Scale (HADS)(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)(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)(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).)
- Frenchay Activities Index (FAI)(Administered (both stroke and sABI) at follow-up T2 (12 months post-stroke; 18 months post-sABI).)
- Fugl Mayer (FM)(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)(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)(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)(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; ).)
研究者
Valentina Varalta
Doctor
Azienda Ospedaliera Universitaria Integrata Verona