PRediction of Vagal Nerve Stimulation EfficaCy In Drug-reSistant Epilepsy: Prospective Study for Pre-implantation Prediction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Accuracy of statistic model for prediction of response to VNS therapy
研究概览
简要总结
Vagal nerve stimulation (VNS) can be indicated in patients with drug-resistant epilepsy who are not eligible for resective epilepsy surgery with responders rates about 50% (≥50% seizure reduction). At the moment, there is not a widely-accepted possibility to predict VNS efficacy in a given patient based on pre-implantation data, which can lead to unnecessary surgery and improper allocation of financial resources. The principal aim of PRECISE (PRediction of vagal nerve stimulation EfficaCcy In drug-reSistant Epilepsy) study is to verify the predictability of VNS efficacy by analysis of pre-implantation routine EEG. The PRECISE relies on the results of our previous work, which developed a statistical classifier for VNS response (responders vs. non-responders) based on differences in EEG power spectra dynamics (Pre-X-Stim). PRECISE is designed as a prospective multicentre study in which patients indicated to VNS therapy will be recruited. Patients will be classified as predicted responders vs. predicted non-responders using pre-implantation EEG analyses. After the first and the second year of the study, the real-life outcome (responder vs. non-responder) will be determined. The real-life outcome and predicted outcome will be compared in terms of accuracy, specificity, and sensitivity. In the meantime, the patients will be managed according to the best clinical practice to obtain the best therapeutical response.
详细描述
The patients will be recruited within cooperating epilepsy centres. The recruitment limited to cooperating centres will ensure the correct indication for VNS therapy and the adjustment of VNS parameters according to the best medical practice, which are not part of the study protocol itself, but are crucial for the study results.
The VNS will be indicated in a given patient based on a clinical decision as a standard of patient´s therapy (i.e., the indication of VNS is not a part of the proposed project). The patient will be informed about the study on a pre-implantation visit or by a phone call, during which initial eligibility for the study will be determined, and study protocol and design will be explained by research staff.
G. Assessment 0 - pre-implantation assessment Assessment 0 includes screening for eligibility criteria and obtaining baseline data on subjects participating in the study. After the signature of informed consent, the patient will be given a unique code by which all data will be labelled. The demographic information, health history, including psychiatric disease and type of epilepsy, concomitant medication (AEDs and other drugs), and seizure frequency will be collected. The seizure frequency will be analysed based on the patient diary. Standard EEG will be recorded according to the protocol described below.
Protocol for EEG recording The EEG will be recorded on the EEG recording system with a sampling frequency of 250 Hz or higher, with electrodes placed on the scalp according to 10-20 system (electrodes names as follows: Fp1, Fp2, F7, F3, Fz, F4, F8, T3, C3, Cz, C4, T4, T5, P3, Pz, P4, T6, O1, and O2). Different electrodes names are allowed, but their position must correspond with the position of previously defined electrodes. Additional electrodes are also allowed, but will not be evaluated within the study. EEGs with lower numbers or different positions of electrodes are not allowed.
The EEG is recorded in a supine position with eyes closed except for periods with eyes opening. The recorded EEG will have a duration of 20 minutes or more and must contain defined segments in the following order (Figure 1):
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Drug-resistant epilepsy indicated to VNS based on clinical decision.
- •Drug-resistant epilepsy is defined as a failure of adequate trials of two tolerated, appropriately chosen, and used antiepileptic drug schedules (whether as monotherapy or in combination) to achieve sustained seizure freedom (Kwan et al., 2010).
- •Age ≥ 18 years
- •Availability to record 20 minutes of EEG with photic stimulation, hyperventilation, and eye-opening/closing according to the pre-defined protocol.
- •Availability of seizure diaries at least three months before VNS implantation OR reliable information about seizure frequency at least three months before VNS implantation
- •The ability of a patient/family member/caregiver to record seizures precisely into seizure diaries OR the ability of a patient/family member/caregiver to report seizures precisely different ways.
- •In cases with very high seizure frequency (several seizures per day), it is acceptable to report only the days without any seizures.
排除标准
- •The indication and planning of resection brain surgery as a treatment option for drug-resistant epilepsy. If a patient clearly demonstrates his refusal of resection surgery, he/she can be included in the study.
- •The presence of psychogenic non-epileptic seizures which cannot be reliably distinguished from epileptic seizures by a patient/family member/caregiver.
- •The presence of other condition which can resemble epileptic seizures which cannot be reliably distinguished from epileptic seizures by a patient/family member/caregiver.
- •Metabolic condition or other diseases, in which the increase of seizure frequency is expectable.
- •The inability of a patient to take regular visits which are required for VNS parameters settings or the study
- •Life expectancy shorter than two years
研究组 & 干预措施
Predicted responders
Patients indicated VNS therapy as their standard for clinical care and are concerned about the prediction of VNS efficacy based on pre-implantation EEG, (≥50% seizure reduction).
干预措施: Statistical model for the prediction of VNS efficacy (Other)
Predicted non-responders
Patients indicated VNS therapy as their standard for clinical care and are concerned about the prediction of VNS efficacy based on pre-implantation EEG, (<50% seizure reduction).
干预措施: Statistical model for the prediction of VNS efficacy (Other)
结局指标
主要结局
Accuracy of statistic model for prediction of response to VNS therapy
时间窗: 2 years
Accuracy of statistic model for prediction of response to VNS therapy in terms of responders and non-responders in drug-resistant epilepsy
次要结局
- The quantification of differences in EEG power spectra(2 years)
- Prediction of patients' response to VNS therapy(2 years)