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临床试验/NCT04553354
NCT04553354Unknown不适用

Evaluation of Safety and Efficacy of Cortical Resections for Seizure Control for Patients With Drug Resistant Epilepsy

Assiut University0 个研究点目标入组 35 人开始时间: 2020年9月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
35
主要终点
control of focal epilepsy in drug resistant epileptic patients

研究概览

简要总结

The aim of the study is to evaluate safety and efficacy of epilepsy surgery in the form of cortical resections in patients with refractory epilepsy and to review outcomes of resection procedures in focal epilepsy.

详细描述

Nearly one-third of epilepsy patients are refractory/resistant to medical treatment . Refractory or drug-resistant epilepsy is defined as resistance to treatment with two appropriately chosen and tolerated antiepileptic drugs (AED) . Nevertheless, epilepsy surgery is an effective alternative treatment for some patients as it suggests seizure freedom . During the past 3 decades, surgery has found more acceptance as an option for drug-resistant epilepsy . Developments made in surgical techniques (cortical resections) have significantly increased the effectiveness and safety of these techniques; as such techniques have been demonstrated to improve seizure control/freedom outcomes and enhanced quality of life in patients . Neuro imaging developments with the introduction of positron emission tomography (PET), magnetic resonance imaging (MRI), functional MRI, single-photon emission computed tomography (SPECT), and magneto encephalography, electroencephalography and neuronavigation have facilitated the presurgical evaluation of patients, thus providing the lesion-directed surgeries more possible , also reducing the number and severity of complications . Complications of epilepsy surgery including failure to stop seizures and neuropsychological, psychosocial, or psychiatric impairment are still difficult to define, and there is no universal consensus in this regard .

This technique characterized by :

• Once the epilepsy focus is located by using interpretation and collection of data from functional MRI, EEG long term video and clinical findings, the specific surgery involved in treatment is decided on. The type of surgery depends on the location of the seizure focal point. Surgeries for epilepsy treatment include, but are not limited to, the following types: temporal lobe resection, ground temporal and extra temporal resection, parietal resection, occipital resection, frontal resection, extra temporal resection.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients with focal epilepsy who are refractory to medical treatment.
  • Patients accept surgical maneuver

排除标准

  • Epileptic patients responding to medical treatment.
  • Patients refusing surgical intervention.
  • Patients unfit for brain surgery.
  • Multi focal or generalized seizures.

结局指标

主要结局

control of focal epilepsy in drug resistant epileptic patients

时间窗: baseline

seizure freedom after cortical resections will be measured by angel classification

decrease incidence of drug adverse effects in drug resistant focal epilepsy

时间窗: baseline

the well known adverse effects of AEDs that are mentioned in literature as affection of the liver and kidney will be measured preoperatively by kidney function and liver function tests to detect if it is normal or not

次要结局

  • change quality of life of patients with drug resistant epilepsy(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Ammar

principal investigator

Assiut University

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