Early Surgical Intervention to Treat Epilepsy (ERSET)

This study has been completed.

First Received: June 24, 2002 Last Updated: February 22, 2010 History of Changes

Sponsor: University of California, Los Angeles

Information provided by: University of California, Los Angeles

ClinicalTrials.gov Identifier: NCT00040326

Purpose

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 Intervention Phase

Epilepsy Procedure: anteromesial temporal resection Phase III
Epilepsy, Temporal Lobe Drug: antiepileptic drugs
Seizures

Study Type: Interventional

Study Design: Allocation: Randomized

Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment

Official Title: Early Randomized Surgical Epilepsy Trial

Resource links provided by NLM:

Genetics Home Reference related topics:

autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-
dependent epilepsy pyridoxine-dependent epilepsy
MedlinePlus related topics: Epilepsy Seizures Surgery

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

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 ]
[ Designated as safety issue: No ]

Estimated Enrollment: 200

Study Start Date: July 2002

Study Completion Date: November 2007

Primary Completion Date: November 2007 (Final data collection date for primary
outcome measure)

Arms Assigned Interventions

1: Active Comparator Procedure: anteromesial temporal resection
anteromesial temporal resection surgical treatment for epilepsy

2: Active Comparator Drug: antiepileptic drugs

antiepileptic drugs pharmacotherapy

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.
Eligibility

Ages Eligible for Study: 12 Years and older

Genders Eligible for Study: Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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 Jerome Engel, Jr., UCLA School of Medicine, Department
Investigator: M.D., Ph.D. of Neurology
More Information

No publications provided

Responsible Party: UCLA School of Medicine, Department of Neurology (

ClinicalTrials.gov Identifier:
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:
Jerome Engel, Jr., M.D., Ph.D. )
NCT00040326 History of Changes
R01NS42372
June 24, 2002
February 22, 2010
United States: Federal Government

Keywords provided by University of California, Los Angeles:

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

Additional relevant MeSH terms:

Epilepsies, Partial Pharmacologic Actions
Epilepsy Signs and Symptoms
Epilepsy, Temporal Lobe Therapeutic Uses
Seizures Neurologic Manifestations
Nervous System Diseases Central Nervous System Agents
Central Nervous System Diseases Anticonvulsants
Brain Diseases
ClinicalTrials.gov processed this record on June 10, 2010