Cortical Resections in Drug Resistant Epilepsy

NCT ID: NCT04553354

Last Updated: 2020-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-10

Study Completion Date

2022-11-10

Brief Summary

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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

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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.

Conditions

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Epilepsy Surgery Drug Resistant Epilepsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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cortical resections

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Ammar

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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mahmoud mostafa ammar, assistant lecturer

Role: CONTACT

+201026998340

Radwan Noby Mahmoud, professor

Role: CONTACT

+201224480595

References

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

Reference Type BACKGROUND
PMID: 10660394 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19889013 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22396514 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12601090 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26749250 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21654716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15758038 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9579911 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24348103 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9048680 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9527007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7925156 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29534299 (View on PubMed)

Other Identifiers

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epilepsy surgery

Identifier Type: -

Identifier Source: org_study_id

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