DRKS00025547已完成未知
A multicenter study to examine clinical scenarios for long-term monitoring of epileptic seizures with a wearable biopotential technology - SeizeIT2
Department of Neurology, UZ Leuven0 个研究点目标入组 495 人开始时间: 2021年8月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 495
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 4 Years 至 70 Years(—)
- 性别
- All
入选标准
- •1.Adults (>18 years old) who have given informed consent. Adults unable to provide consent or illiterate individuals can participate provided a caregiver or proxy can give informed consent.
- •2.Children (4-18 years old), if a parent can provide consent.
- •3.Refractory epilepsy, including refractory idiopathic absence epilepsy with typical absences (childhood absence or juvenile absence epilepsy)
- •4.Patients with focal epilepsy, who will undergo a presurgical evaluation
排除标准
- •1.Inability to provide written informed consent, either directly or via a guardian.
- •2.Known allergy to electrodes used as part of the study protocol.
- •3.Having an implanted device, including (but not limited to) a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device
- •4.Any other condition or finding that would compromise the safety of the participant or the quality of the study data, or otherwise interfere with achieving the study objectives, as determined by the investigator or research coordinator.
- •5.Pregnant women, neonates, employees or students of the participating enrolment centres, prisoners, and individuals whose first language is not English or that of the host country.
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