NL-OMON32514撤回不适用
IMAGINE-study (Imaging study in epilepsy) Is there a neuronal correlate for cognitive impairment and response to antiepileptic drugs in children with frontal lobe epilepsy? - IMAGINE-Study (Imaging study in epilepsy)
Epilepsie Centrum Kempenhaeghe0 个研究点目标入组 130 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •calibration study:
- •Adults aged 18 years or older
- •Normal intelligence;Patients with frontal lobe epilepsy:
- •Patients aged 8 to18 years
- •Clinical and electroencephalographic evidence of seizures originating from the frontal lobe. When EEG is not informative, we require the recording of more than one seizure with clinical evidence of seizures originating from the frontal lobe (Provini et al (1)).
- •Non-symptomatic epilepsy;Healthy control group:
- •Children aged 8 to 18 years
- •Normal intelligence/following regular schools
排除标准
- •Exclusion criteria for the healthy adult group for the calibration study:
- •Medical history of head trauma or other diseases/ causes that may underlie cognitive impairment (i.e. psychiatric diseases, unable to speak/understand the Dutch language)
- •Vision less than +4.5D or - 4.5D
- •Claustrophobia
- •Metal implants or other contraindication for MRI
- •Persons who do not want to get informed whenever structural abnormalities are found during imaging;Exclusion criteria for children with FLE:
- •Multiple seizure foci involving more than one lobe of the brain documented on previous EEG studies
- •Frontal lobe seizures thought to be a result of spread to the frontal lobes
- •MRI lesions on previous structural brain MRI- or CT-scans or symptomatic epilepsy (e.g. tumours, vascular abnormalities, congenital dysgenesia)
- •Full scale IQ<70 on the Wechsler Intelligence Scale for Children-Third Edition (Wechsler 1991).
- •Progressive neurological disorders
- •Other diseases/ causes that may underlie cognitive impairment (i.e. psychiatric diseases, unable to speak/understand the Dutch language)
- •Cognitive deterioration directly after starting with AED, or treatment with Topiramate or Phenobarbital
- •Vision less than +4.5D or - 4.5D
- •Claustrophobia
- •Metal implants or other contraindication for MRI
- •Parents not willing to provide informed consent;Exclusion criteria for the healthy control children:
- •Medical history of head trauma or other diseases/ causes that may underlie cognitive impairment (i.e. psychiatric diseases, unable to speak/understand the Dutch language)
- •Vision less than +4.5D or - 4.5D
- •Claustrophobia
- •Metal implants or other contraindication for MRI
- •Parents not willing to provide informed consent
- •Parents who do not want to get informed whenever structural abnormalities are found during imaging
研究者
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