NCT04553354

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 10, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2022

Completed
Last Updated

September 17, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

September 9, 2020

Last Update Submit

September 15, 2020

Conditions

Epilepsy SurgeryDrug Resistant Epilepsy

Outcome Measures

Primary Outcomes (2)

  • control of focal epilepsy in drug resistant epileptic patients

    seizure freedom after cortical resections will be measured by angel classification

    baseline

  • 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

    baseline

Secondary Outcomes (1)

  • change quality of life of patients with drug resistant epilepsy

    baseline

Interventions

cortical resectionsPROCEDURE

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients with focal epilepsy not responding to medical treatment

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (13)

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

    PMID: 10660394BACKGROUND

  • 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.

    PMID: 19889013BACKGROUND

  • 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.

    PMID: 22396514BACKGROUND

  • 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.

    PMID: 12601090BACKGROUND

  • 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.

    PMID: 26749250BACKGROUND

  • 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.

    PMID: 21654716BACKGROUND

  • 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.

    PMID: 15758038BACKGROUND

  • 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.

    PMID: 9579911BACKGROUND

  • 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.

    PMID: 24348103BACKGROUND

  • 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.

    PMID: 9048680BACKGROUND

  • 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.

    PMID: 9527007BACKGROUND

  • 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.

    PMID: 7925156BACKGROUND

  • 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.

    PMID: 29534299BACKGROUND

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

mahmoud mostafa ammar, assistant lecturer

CONTACT

+201026998340dr.mahmoud.ammar90@gmail.com

Radwan Noby Mahmoud, professor

CONTACT

+201224480595hannahomar@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 9, 2020

First Posted

September 17, 2020

Study Start

September 10, 2020

Primary Completion

September 10, 2022

Study Completion

November 10, 2022

Last Updated

September 17, 2020

Record last verified: 2020-09