Early Surgical Intervention to Treat Epilepsy
Early Surgical Intervention to Treat Epilepsy
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.
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.
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.