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

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
|
- 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 ]

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

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
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 |
Principal Investigator: | Jerome Engel, Jr., M.D., Ph.D. | UCLA School of Medicine, Department of Neurology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |