Cortical Resections in Drug Resistant Epilepsy
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| ClinicalTrials.gov Identifier: NCT04553354 |
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Recruitment Status :
Not yet recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
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| Condition or disease | Intervention/treatment |
|---|---|
| Epilepsy Surgery Drug Resistant Epilepsy | Procedure: cortical resections |
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 |
| Estimated Enrollment : | 35 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Evaluation of Safety and Efficacy of Cortical Resections for Seizure Control for Patients With Drug Resistant Epilepsy |
| Estimated Study Start Date : | September 10, 2020 |
| Estimated Primary Completion Date : | September 10, 2022 |
| Estimated Study Completion Date : | November 10, 2022 |
- Procedure: cortical resections
is the removal of the epileptic focus either temporal or extra temporal area
- 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
- 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
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553354
| Contact: mahmoud mostafa ammar, assistant lecturer | +201026998340 | dr.mahmoud.ammar90@gmail.com | |
| Contact: Radwan Noby Mahmoud, professor | +201224480595 | hannahomar@yahoo.com |
| Responsible Party: | Mahmoud Ammar, principal investigator, Assiut University |
| ClinicalTrials.gov Identifier: | NCT04553354 |
| Other Study ID Numbers: |
epilepsy surgery |
| First Posted: | September 17, 2020 Key Record Dates |
| Last Update Posted: | September 17, 2020 |
| Last Verified: | September 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Epilepsy Drug Resistant Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |