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Epilepsy SurgeryNCT04553354

Cortical Resections in Drug Resistant Epilepsy

An observational study of Epilepsy Surgery and Drug Resistant Epilepsy, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Epilepsy Surgery, Drug Resistant Epilepsy
What is being tested?
cortical resections
Type of treatment
Surgery or procedure
How many people
35 participants
Where
No sites listed yet
Study dates
10 Sep 2020to 10 Nov 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: all patients with focal epilepsy not responding to medical treatment

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

mahmoud mostafa ammar, assistant lecturer contact

+201026998340

dr.mahmoud.ammar90@gmail.com

Radwan Noby Mahmoud, professor contact

+201224480595

hannahomar@yahoo.com

About this study

Official title: 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.

Read the 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.
Being tested
cortical resections
Medical subject headings
Drug Resistant Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cortical resectionsProcedure or surgery

    is the removal of the epileptic focus either temporal or extra temporal area

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. control of focal epilepsy in drug resistant epileptic patients

    seizure freedom after cortical resections will be measured by angel classification

    Measured: baseline

  2. decrease incidence of drug adverse effects in drug resistant focal epilepsy

    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

    Measured: baseline

Secondary outcomes (1)

  1. change quality of life of patients with drug resistant epilepsy

    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

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2020
  2. Study start10 Sep 2020 (estimated)
  3. Primary completion10 Sep 2022 (estimated)
  4. Study completion10 Nov 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04553354
Sponsor's protocol ID
epilepsy surgery
Status last verified
Sep 2020
First submitted
9 Sep 2020
Last updated
17 Sep 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.

    PubMed 10660394

  • Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3.

    PubMed 19889013

  • Engel J Jr, McDermott MP, Wiebe S, Langfitt JT, Stern JM, Dewar S, Sperling MR, Gardiner I, Erba G, Fried I, Jacobs M, Vinters HV, Mintzer S, Kieburtz K; Early Randomized Surgical Epilepsy Trial (ERSET) Study Group. Early surgical therapy for drug-resistant temporal lobe epilepsy: a randomized trial. JAMA. 2012 Mar 7;307(9):922-30. doi: 10.1001/jama.2012.220.

    PubMed 22396514

  • Engel J Jr, Wiebe S, French J, Sperling M, Williamson P, Spencer D, Gumnit R, Zahn C, Westbrook E, Enos B; Quality Standards Subcommittee of the American Academy of Neurology; American Epilepsy Society; American Association of Neurological Surgeons. Practice parameter: temporal lobe and localized neocortical resections for epilepsy: report of the Quality Standards Subcommittee of the American Academy of Neurology, in association with the American Epilepsy Society and the American Association of Neurological Surgeons. Neurology. 2003 Feb 25;60(4):538-47. doi: 10.1212/01.wnl.0000055086.35806.2d.

    PubMed 12601090

  • Cukiert A, Rydenhag B, Harkness W, Cross JH, Gaillard WD; Task Force for Pediatric Epilepsy Surgery for the ILAE Commissions of Pediatrics and Surgical Therapies. Technical aspects of pediatric epilepsy surgery: Report of a multicenter, multinational web-based survey by the ILAE Task Force on Pediatric Epilepsy Surgery. Epilepsia. 2016 Feb;57(2):194-200. doi: 10.1111/epi.13292. Epub 2016 Jan 8.

    PubMed 26749250

  • Berg AT. Epilepsy: Efficacy of epilepsy surgery: what are the questions today? Nat Rev Neurol. 2011 Jun 8;7(6):311-2. doi: 10.1038/nrneurol.2011.73.

    PubMed 21654716

  • Tellez-Zenteno JF, Dhar R, Wiebe S. Long-term seizure outcomes following epilepsy surgery: a systematic review and meta-analysis. Brain. 2005 May;128(Pt 5):1188-98. doi: 10.1093/brain/awh449. Epub 2005 Mar 9.

    PubMed 15758038

  • Malmgren K, Sullivan M, Ekstedt G, Kullberg G, Kumlien E. Health-related quality of life after epilepsy surgery: a Swedish multicenter study. Epilepsia. 1997 Jul;38(7):830-8. doi: 10.1111/j.1528-1157.1997.tb01471.x.

    PubMed 9579911

  • Engel J Jr. Why is there still doubt to cut it out? Epilepsy Curr. 2013 Sep;13(5):198-204. doi: 10.5698/1535-7597-13.5.198.

    PubMed 24348103

  • A global survey on epilepsy surgery, 1980-1990: a report by the Commission on Neurosurgery of Epilepsy, the International League Against Epilepsy. Epilepsia. 1997 Feb;38(2):249-55. doi: 10.1111/j.1528-1157.1997.tb01105.x. No abstract available.

    PubMed 9048680

  • Rafael H. Surgical and neurological complications in a series of 708 epilepsy surgical procedures. Neurosurgery. 1998 Mar;42(3):675-6. doi: 10.1097/00006123-199803000-00048. No abstract available.

    PubMed 9527007

  • Cascino GD, Sharbrough FW, Trenerry MR, Marsh WR, Kelly PJ, So E. Extratemporal cortical resections and lesionectomies for partial epilepsy: complications of surgical treatment. Epilepsia. 1994 Sep-Oct;35(5):1085-90. doi: 10.1111/j.1528-1157.1994.tb02559.x.

    PubMed 7925156

  • Vakharia VN, Duncan JS, Witt JA, Elger CE, Staba R, Engel J Jr. Getting the best outcomes from epilepsy surgery. Ann Neurol. 2018 Apr;83(4):676-690. doi: 10.1002/ana.25205. Epub 2018 Apr 10.

    PubMed 29534299

Questions about this trial

What is this clinical trial studying?

An observational study of Epilepsy Surgery and Drug Resistant Epilepsy, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact mahmoud mostafa ammar, assistant lecturer (+201026998340, dr.mahmoud.ammar90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

control of focal epilepsy in drug resistant epileptic patients (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04553354, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.

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