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Clinical Trials/NCT04553354
NCT04553354
Unknown
Not Applicable

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

Assiut University0 sites35 target enrollmentSeptember 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy Surgery
Sponsor
Assiut University
Enrollment
35
Primary Endpoint
control of focal epilepsy in drug resistant epileptic patients
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
September 10, 2020
End Date
November 10, 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Ammar

principal investigator

Assiut University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

control of focal epilepsy in drug resistant epileptic patients

Time Frame: baseline

seizure freedom after cortical resections will be measured by angel classification

decrease incidence of drug adverse effects in drug resistant focal epilepsy

Time Frame: 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

Secondary Outcomes

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

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