Investigation of Behaviour by Dogs Prior to Human Epileptic Seizures and Potential Underlying Mechanisms. Part III: Olfactive Discriminative Ability of Dogs When Confronted With Seizure and Non-seizure Samples Part IV: Identification of Potential Biomarkers for Epilepsy in Human Sweat.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- VOC Identification
研究概览
简要总结
Dogs belonging to MDD will be trained and asked to discriminate between odour sweat samples from epilepsy patients associated with a seizure ("seizure sample") and samples collected when no seizure was close in time ("non-seizure sample").
The same type positive and negative sweat samples will be analysed by Florida International University using solid phase micro extraction (SPME) GC-MS to try to identify volatile organic components (VOC) specific to the samples associated with seizures.
详细描述
For this research, three different types of samples will be collected
- seizure samples from patients: (S+)
- non-seizure samples from patients : (S-)
- samples from healthy people (H)
- positive control samples consisting of a standard chemical mix (C+) (Only for part IV)
- negative control samples with gauze exposed to the environment in which the samples from patients and healthy people are taken). (C-) (Only for part IV)
2.1 Collection of type a and b samples (from patients)
Sweat samples will be collected from epilepsy patients admitted for clinical purposes in the 4 EEG units at the UZ. At the time of admission, they will be asked if they agree to collaborate with the study and with their samples being taken. The patients' care is the responsibility of the staff of Ghent University Hospital. The researcher from this study will be present to collect samples in consultation with the nursing staff.
Sample collection
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The person will be an adult.
- •The person will experience seizures implying both or either loss of conscience or incapability of interacting normally with the environment.
- •Diagnostic of epilepsy confirmed by treating neurologist
排除标准
- 未提供
结局指标
主要结局
VOC Identification
时间窗: 8 months
Identification of volatile organic molecules (VOC) specific to seizure samples should they be present in human sweat
Answer to the question: Is possible to train Medical Detection Dogs to identify seizure-related samples using the sense of olfaction?
时间窗: 8 months
Success rate of medical detection dogs when discriminating between seizure associated and non-seizure associated samples (success rate of 40% needed to be compared with a theoretical ratio of 14.3%)
次要结局
未报告次要终点