跳至主要内容
临床试验/NCT06805721
NCT06805721招募中不适用

OUTCOME in NEURORADIOLOGIA INTERVENTISTICA INDICAZIONI COMPLICANZE (ONIRIC)

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年2月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
1,000
试验地点
1
主要终点
Safety and Efficacy of the Endovascular procedures

研究概览

简要总结

This three-year observational study involves patients of all ages undergoing endovascular treatment for various cerebral or spinal vascular conditions. It aims to assess pre- and post-operative clinical conditions, report complications, and identify preoperative indicators of treatment outcomes. Patients will also receive psychological support and Neuropsychological assessment. Clinical, medical, and demographic data will be recorded in a database during hospitalization and follow-up visits.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients of both sexes and any age, who are referred to the Department of Neurosurgery and Clinical Neurosciences and are candidates for interventional endovascular procedures for any cerebral or spinal pathology, will be included in the study.

排除标准

  • 未提供

结局指标

主要结局

Safety and Efficacy of the Endovascular procedures

时间窗: 1 year after treatment

Describe the safety and efficacy of endovascular procedures performed for cerebro-spinal vascular diseases or hypervascularized lesions treated in the institute either through endovascular means or direct puncture. In order to the describe safety and efficay, the analysis will report the number and the nature of clinical and technical adverse events related or unrelated to a device deficiency, as assessed by CTCAE v4.0. Moreover ther will be a qualitative and quantitive (Landriel-Ibanez scale) report of the complications, and the clinical outcomes (NIHSS, mRS, Aminoff-Loug scale).

Landriel-Ibanez Scale

时间窗: 1 year after treatment

Assesses functional outcome and recovery in patients, often after neurological injuries or interventions. Scores range from 0 to 4: 0 indicates no deficits, while higher scores indicate worse functional outcomes or greater levels of disability.

National Institutes of Health Stroke Scale (NIHSS)

时间窗: 1 year after treatment

Quantifies the severity of neurological impairment in stroke patients, focusing on motor, sensory, language, and visual deficits. Scores range from 0 to 42: 0 indicates no neurological deficits, Scores 1-4 Minor stroke, Scores 5-15 Moderate stroke, Scores 16-20 Moderate-to-severe stroke, Scores 21-42 Severe stroke. Higher scores indicate greater stroke severity.

Modified Rankin Scale (mRS)

时间窗: 1 year after treatment

Assesses the degree of disability or dependence in daily activities after a stroke or other neurological conditions. Scores range from 0 to 6, with higher scores indicate worse outcomes or greater levels of disability.

Aminoff-Loug Scale

时间窗: 1 year after treatment

Evaluates functional impairments. It focuses on mobility and dependency in activities of daily living. Scores range from 0 to 5 with higher scores reflecting increasing disability and dependence in daily living activities.

Neursopychological status and Quality of life:

时间窗: 1 year after treatment

Describe the neuropsychological status and quality of life of the patient before and after (3month/6month Follow-Up and 1 year Follow-Up) the execution of such procedures. The goal is to better understand if there will be a significative change regarding such variables. The questionnaire and tests used for such assessment are listed below.

World Health Organization Disability Assessment Schedule (WHODAS):

时间窗: 1 year after treatment

Assesses disability and impairment in various life domains, with score ranging fro 0 to 100, where higher scores indicate higher disability. This scale will be part of the quality of life assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

EQ-5D-5L

时间窗: 1 year after treatment

Assesses health-related quality of life across five domains (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Each domain has a score range fro 1 to five, where higher scores reflect lower quality of life. The VAS (Visual Analogue Scale) can be used as a quantitative measure of health outcome that reflects the patient's own judgement, with a score range from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine"). This scale will be part of the quality of life assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

State and Traits Anxiety Inventory (STAI)

时间窗: 1 year after treatment

Assesses anxiety in two dimensions: state anxiety (temporary and situation-specific) and trait anxiety (a stable characteristic). Each dimension ranges from 20 to 80, with Higher scores indicate higher levels of anxiety. This scale will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

Beck Depression Inventory (BDI-II)

时间窗: 1 year after treatment

Evaluates the severity of depressive symptoms. Score ranges from 0 to 63, higher scores indicate more severe depression. This scale will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

Coping Orientation to Problems Experienced Inventory (Brief-COPE)

时间窗: 1 year after treatment

Evaluates coping strategies in response to stress. Each subscale ranges from 2 to 8, with different strategies assessed (e.g., active coping, avoidance), Scores indicate the extent to which specific coping strategies are used, with no direct "better" or "worse. This scale will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

Mini Mental State Examination (MMSE)

时间窗: 1 year after treatment

Assessing generic cognitive function. Raw scores range from 0 to 30, according to Maesso 1993 and Magni 1996, with higher scores indicating better cognitive fuctioning. The raw score are corrected by age and educationT This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

Raven Progressive Matrices (RPM)

时间窗: 1 year after treatment

Assees Nonverbal reasoning and problem-solving abilities. Raw Scores, according to the version of Carlesimo et. Al. 1995, range from 0 to 36, then corrected by eduction and age and converted toequivalent scores. Higher scores means better perfomance. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

Ray Auditory Verbal Learning Test (RAVLT)

时间窗: 1 year after treatment

Assesses verbal learning and memory. Higher scores indicate better memory performance, with lerning scores range fro 0 to 75 and log term memory from 0 to 15. Raw scores, according to the version of Carlesimo et. Al. 1996, are then corrected by age and education and converted into equivalent scores. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

Rey-Osterrieth Complex Figure (ROCF)

时间窗: 1 year after treatment

Assesses visuospatial ability, memory, and planning through figure reproduction and recall. Raw scores range from 0 to 36 for both reproduction and recall and, according to the version of Caffarra et. Al. 2002, are then corrected by education and age and converted to equivalent scores. Higher scores indicate better visuospatial and memory performance. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

Trail Making Test - A and B (TMT-A-B)

时间窗: 1 year after treatment

Measures visual attention, task-switching, and processing speed (TMT-A: sequencing numbers; TMT-B: alternating between numbers and letters). The score is determined by the time used to complete the tasks, the higher it is the poorer is the performance. Raw time scores are then corrected by age and education and then converted into equivalent scores, according to the version of Giovagnoli et al.1996. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

F-A-S Phonemic Verbal Fluency Test

时间窗: 1 year after treatment

Assesses verbal fluency by generating words starting with specific letters (e.g., F, A, S) within 60 seconds. The higher is the number of words produced, the higher the performance. The raw score is then corrected by age and education and then converted into equivalent scores, according to the version of Carlesimo et al. 1995. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

Category Verbal Fluency Test

时间窗: 1 year after treatment

Assesses semantic verbal fluency by generating words within specific categories (e.g., animals) in 60 seconds. The higher is the number of words produced, the higher the performance. The raw score, the number of words produced in the set time, is then corrected by age and education and then converted into equivalent scores, according to the version of Carlesimo et al. 1995. This test will be part of the Neuropsychological assessment at each time point (pre intervention, post intevention, 3month Follow up, and 1 year follow up).

Verbal Digit Span

时间窗: 1 year after treatment

Assesses short term memoty (forward) and workin memory (backward). The score is determined by the amount of numers that the patiente reports correctly (span). The raw score is then corrected by age and education and then converted into equivalent scores, according to the version of Monaco et al. 2012.

Frontal Assessment Battery (FAB)

时间窗: 1 year after treatment

Assesses various executive function (Conceptualization, Mental flexibility, Motor programming, Sensitivity to interference, Inhibitory control and environmental autonomy). For each dimension the score range is from 0 to 3, resulting in a total score of 18. The raw score is then corrected by age and education and then converted into equivalent scores, according to the version of Apollnio et al. 2005.

Stroop Test

时间窗: 1 year after treatment

The test consist of three different parts (words, color and word-color) and assesses processing speed, attention and inhibitory control. The performance is determined by time and errrors in completing the task. Both time and errors raw scores, after being processed through the dedicated formula, are then corrected by age and education and the converted in equivalent scores, according to Cafarra et al. 2002.

次要结局

  • Preprocedural outcome identification(pre-procedure)
  • Socio-demographic variables(pre-procedure)
  • Comorbidities(pre-procedure)
  • Pre-procedure medical treatment(pre-procedure)
  • Morphology of the endovascular pathology(pre-procedure)
  • Dimension in mm(pre-procedure)
  • Location(pre-procedure)

研究者

发起方
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验