The Role of Cerebral Functional, Structural and Spectral Imaging in the Diagnosis, Management and Prognosis of Status Epilepticus: a Prospective Study in Patients with the Ictal-interictal Continuum
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Sensitivity of MRI arterial spin labelling, CT perfusion and FDG-PET of the brain to detect hyperperfusion/hypermetabolism in possible non-convulsive status epilepticus
研究概览
简要总结
The investigators propose a prospective study of 20 control subjects and 180 consecutive patients with possible non-convulsive status epilepticus (NCSE). The investigators will obtain three functional images of the brain:
- Fluorodeoxyglucose positron emission tomography (FDG-PET)
- Perfusion (and structural) magnetic resonance (MR) images
- Computed tomography (CT) perfusion.
Brain hypermetabolism/hyperperfusion is a strong argument to confirm a diagnosis of non-convulsive status epilepticus.
The aim is to determine which of the three functional imaging techniques is the most sensitive and easy to obtain in the detection of hypermetabolism/hyperperfusion. The investigators will determine which EEG patterns are associated with hypermetabolism/perfusion.
The investigators will further study and describe the management with antiseizure medication and outcome of the group with possible non-convulsive status epilepticus WITH hypermetabolism/hyperperfusion versus the group with possible non-convulsive status epilpticus WITHOUT hypermetabolism/hyperperfusion.
The investigators will make recommendations for an imaging protocol in possible NCSE for widespread use. The aim is to offer guidelines to incorporate imaging in the diagnosis, management and prognosis of NCSE in patients with the ictal-interictal continuum.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The patient has possible non-convulsive status epilepticus with scalp or invasive EEG with ictal-interictal continuum patterns on EEG
排除标准
- •The patient has a contra-indication for MRI such as metal implants
- •The patient has contrast sensitivity
- •The patiensuffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures
结局指标
主要结局
Sensitivity of MRI arterial spin labelling, CT perfusion and FDG-PET of the brain to detect hyperperfusion/hypermetabolism in possible non-convulsive status epilepticus
时间窗: Day 1
The investigators will determine which diagnostic test (MRI, CT or FDG-PET) is most sensitive in detecting hyperperfusion/hypermetabolism in possible non-convulsive status epilepticus to confirm a diagnosis of non-convulsive status epilepticus
Correlation between FREQUENCY of ictal-interictal EEG patterns within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.
时间窗: Day 1
The investigators will assess the correlation between standardised uptake value of the cerebral hypermetabolic region and the frequency of ictal-interictal EEG patterns within 30 minutes after injection of FDG. The frequency of ictal-interictal EEG patterns will be scored semi-quantitatively based on the American Clinical Neurophysiology Criteria (ACNS) criteria (2021).
Correlation between PREVALENCE of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.
时间窗: Day 1
The investigators will assess the correlation between standardised uptake value of the cerebral hypermetabolic region and the prevalence of ictal-interictal EEG patterns within 30 minutes after injection of FDG. The prevalence of ictal-interictal EEG patterns will be scored semi-quantitatively based on the American Clinical Neurophysiology Criteria (ACNS) (2021)
The seizure freedom of patients with hypermetabolism compared to those with hypometabolism within 24 hours after undergoing an FDG-PET scan.
时间窗: Day 1
The investigators will assess the seizure freedom of patients in the hypermetabolic vs hypometabolic group. Patients will receive video EEG-monitoring for 24 hours after FDG-PET. Seizures will be defined according to current American Clinical Neurophysiology Criteria (ACNS) (2021) based on electrographic and clinical data. Hypermetabolism/hypometabolism will be qualitatively scored by a trained nuclearist.
次要结局
- Functional imaging in possible non-convulsive status epilepticus and OUTCOME(Day 30)
- Correlation between EVOLUTION of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.(Day 1)
- Functional imaging in possible non-convulsive status epilepticus and INTERICTAL BURDEN(Day 7)
- Correlation between SHARPNESS of ictal-interictal EEG patterns on EEG within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET.(Day 1)
- Correlation between AMPLITUDE of ictal-interictal EEG patterns within 30 minutes after FDG-PET injection and standardised uptake value on FDG-PET(Day 1)
- Functional imaging in possible non-convulsive status epilepticus and ANTISEIZURE MEDICATION (ASM)(Day 30)