Cortical Resections in Drug Resistant Epilepsy

September 15, 2020 updated by: Mahmoud Ammar, Assiut University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

35

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients with focal epilepsy not responding to medical treatment

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
control of focal epilepsy in drug resistant epileptic patients
Time Frame: baseline
seizure freedom after cortical resections will be measured by angel classification
baseline
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
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change quality of life of patients with drug resistant epilepsy
Time Frame: baseline
changing quality of life of those patients as regards socioeconomic status of the patients if they get a jop or not and remain in his jop or not and the financial status improved or not and all of this will be mentioned by the patients in follow up in out patient clinic
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 10, 2020

Primary Completion (Anticipated)

September 10, 2022

Study Completion (Anticipated)

November 10, 2022

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 17, 2020

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • epilepsy surgery

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Drug Resistant Epilepsy

Clinical Trials on cortical resections

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe