STUDY of NEUROLOGICAL COMPLICATIONS of LONG COVID-19 in CHILDREN and ADOLESCENTS; NEUROPSYCHIATRIC, ELECTROENCEPHALOGRAPHIC and NEURORADIOLOGICAL INVESTIGATIONS
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in cognitive and neuropsychological functions in children and adolescents with Long COVID between T0 and T1.
研究概览
简要总结
The study seeks to investigate the neurological effects caused by Covid-19 in children and adolescents in the 6-16 age group. To do this, neuropsychological scales, an EEG and an MRI were used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 6 years and 16 years and 11 months
- •Symptomatology compatible with long neurological COVID, specifically: persistence or appearance of new neurological signs/symptoms (e.g. fatigue, headache, sleep disturbance, cognitive dysfunction, memory difficulties, emotional or mood disorders, vertigo cognitive dysfunction, memory difficulties, emotional or mood disorders, dizziness, dysautonomia, movement disorders movement disorders, ataxia, tremor, epilepsy, muscle weakness, myalgia, hyposmia, hypogeusia hearing loss or tinnitus and/or sensorimotor deficits such as hypoesthesia, dysesthesia) after three months after established SARS-CoV-2 infection, as well as persistence of these symptoms for at least two months, in the absence of a clear aetiology.
- •Signature of the appropriate Informed Consent by caregiver(s) and patient(s)
排除标准
- •Poor knowledge of the Italian language or other limitation of verbal communication that compromises the subject's ability to perform neuropsychological tests
- •Need for sedation to perform brain MRI 7 Tesla
- •Neurological or neuropsychiatric disorder diagnosed prior to COVID-19 diagnosis
- •Caregiver's failure to sign consent
研究组 & 干预措施
Studio NENCA sulle complicanze neurologiche del Long Covid-19 nei bambini e negli adolescenti
Patients are administered some psychological tests, if they are positive they move on to the next stage, otherwise the patients leave the practice. If they are positive, EEG, MRI and other psychological tests are also administered.
干预措施: Psychological tests, EEG, Magnetic Resonance (Diagnostic Test)
结局指标
主要结局
Changes in cognitive and neuropsychological functions in children and adolescents with Long COVID between T0 and T1.
时间窗: Test administration at the time of diagnosis of Long COVID (T0) and follow-up after 6-9 months (T1).
Assessment of cognitive, neuropsychological and adaptive skills in children and adolescents with Long COVID by means of standardised tests (WISC-IV, CPT3, NEPSY II, BRIEF-2, Vineland Adaptive Behavior Scales). The tests measure attention, memory, executive functions, intellectual-adaptive functioning and quality of life.
次要结局
未报告次要终点
研究者
alessandro orsini
Alessandro Orsini
Azienda Ospedaliero, Universitaria Pisana