Early Surgical Intervention to Treat Epilepsy (ERSET)

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ClinicalTrials.gov Identifier: NCT00040326

Recruitment Status : Completed

First Posted : June 25, 2002

Last Update Posted : February 23, 2010

Sponsor:

Information provided by:

University of California, Los Angeles

Study Description

Brief Summary:

The purpose of this trial is to compare the effectiveness of early surgical intervention for mesial temporal lobe epilepsy to continued treatment with antiepileptic drugs.

Condition or disease	Intervention/treatment	Phase
Epilepsy Epilepsy, Temporal Lobe Seizures	Procedure: anteromesial temporal resection Drug: antiepileptic drugs	Phase 3

Detailed Description:

Mesial temporal lobe epilepsy (MTLE) is the most common form of epilepsy, and the most medically intractable. An estimated one-quarter to one-half of the 400,000 patients in the United States with intractable epilepsy have MTLE. Generally, MTLE becomes intractable in adolescence and early adulthood. Persistence of seizures during this time commonly causes adverse social and psychological consequences which can become irreversible.

The current treatment of MTLE primarily consists of medications to control seizures. Usually surgical treatment is considered only if medications are not effective. Recent studies have shown that surgery can stop disabling seizures in 60 to 70% of patients with long standing MTLE. However, to date, no research study has examined surgery performed as an early therapy.

The goal of the study is to determine if more patients treated with early surgery become seizure free and have improved quality of life compared to similar patients who continue to receive antiepileptic medication only. This study will determine the difference in seizure frequency between the two groups and the impact of the two treatments on the quality of life of the participants.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Early Randomized Surgical Epilepsy Trial
Study Start Date :	July 2002
Actual Primary Completion Date :	November 2007
Actual Study Completion Date :	November 2007

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1 anteromesial temporal resection	Procedure: anteromesial temporal resection surgical treatment for epilepsy
Active Comparator: 2 antiepileptic drugs	Drug: antiepileptic drugs pharmacotherapy

Outcome Measures

Primary Outcome Measures :

The primary outcome measure will be freedom from disabling epileptic seizures (complex partial and secondarily generalized seizures, and simple partial seizures that are apparent to an observer) [ Time Frame: 2 years ]

Eligibility Criteria

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Ages Eligible for Study:	12 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Intractability: Two AEDs, one of which was either Dilantin, Tegretol, Carbatrol, or Trileptal used in appropriate doses, have failed due to inefficacy, not intolerance.
Frequency and Duration: Persistence of disabling seizures at 6 per year or greater for less than two years after onset, or after recurrence if initial treatment resulted in seizure freedom for 6 or more months.
Age: 12 years or older at baseline visit.
History: Simple and complex partial seizures, with or without secondarily generalized seizures beginning in childhood or later, with or without febrile convulsions earlier.
Absence of a history of serious cerebral insult after the age of 5; a progressive neurological disorder; mental retardation (I.Q. less than 70); psychogenic seizures; focal neurological deficits other than memory disturbances; unequivocal focal extratemporal EEG slowing or interictal spikes; or lesions on neuroimaging outside of the mesial temporal area.
Seizure semiology: Auras that occur in isolation and are not primary sensory other than olfactory or gustatory. Absence of initial focal motor movements other than automatisms or dystonic posturing. Presence of postictal confusion.
Neurological examination: No unexplained focal or lateralized neurological deficits other than memory dysfunction.
Baseline QOL and ancillary outcome data:
Adolescents - QOLIE-48-AD, CHQ, CBCL, PANAS, Life Events Scale, FAC, FEICS-PC completed.
Adults - QOLIE-82/ESI55, locus of control, PANAS, Life Events Scale, FAD, FEICS-PC completed.
Global rating scale completed.
Baseline ancillary outcomes completed. Psychiatric evaluation: No evidence of psychosis, current or recent substance abuse, suicidality, anorexia, or psychogenic seizures. Baseline BSI and MINI or KSADS completed.
Neuropsychological testing: I.Q. of greater than 70. No significant focal neurocognitive dysfunction inconsistent with MRI and PET findings. Baseline neuropsychological testing completed.
Neuroimaging: Hippocampal atrophy on MRI T1 imaging with either increased ipsilateral mesial signal on T2 imaging, or ipsilateral hypometabolism on PET (Class I), or either hippocampal atrophy on MRI only, or temporal hypometabolism on PET only (Class II).
Absence of temporal neocortical or extratemporal lesions on MRI, or diffuse unilateral or bilateral hypometabolism on PET.
Video-EEG Monitoring:
If neuroimaging is Class I, ictal EEG onset is lateralized to the ipsilateral side; if neuroimaging is Class II, ictal EEG onset is focal on the ipsilateral side.
Absence of contralateral or extratemporal ictal onset.
Absence of persistent extratemporal, or predominant contralateral focal interictal spikes or slowing, or generalized interictal spikes.
Absence of psychogenic seizures.
Seizure baseline: Seizure log, seizure report forms, and seizure severity scale completed.
IAP: In those randomized to surgery only, contralateral hemisphere can support memory.

Contacts and Locations

Information from the National Library of Medicine

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): NCT00040326

Locations


United States, Arizona
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
United States, California
UCLA School of Medicine, Department of Neurology
Los Angeles, California, United States, 90095-1769
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Michigan
University of Michigan, Department of Neurology
Ann Arbor, Michigan, United States, 48109-0036
United States, New York
University of Rochester, Department of Neurology
Rochester, New York, United States, 14642
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37212
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122

Sponsors and Collaborators

University of California, Los Angeles

Investigators


Principal Investigator:	Jerome Engel, Jr., M.D., Ph.D.	UCLA School of Medicine, Department of Neurology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.


Responsible Party:	Jerome Engel, Jr., M.D., Ph.D., UCLA School of Medicine, Department of Neurology
ClinicalTrials.gov Identifier:	NCT00040326 History of Changes
Other Study ID Numbers:	R01NS42372
First Posted:	June 25, 2002 Key Record Dates
Last Update Posted:	February 23, 2010
Last Verified:	February 2010

Keywords provided by University of California, Los Angeles:


epilepsy mesial temporal lobe epilepsy temporal lobe epilepsy MTLE seizures	anteromesial temporal resection surgery antiepileptic drugs hippocampal sclerosis

Additional relevant MeSH terms:


Epilepsy Seizures Epilepsy, Temporal Lobe Brain Diseases Central Nervous System Diseases	Nervous System Diseases Neurologic Manifestations Signs and Symptoms Epilepsies, Partial Anticonvulsants

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