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Home > "E" Clinical Trials Conditions > Early Surgical Intervention to Treat Epilepsy  Early Surgical Intervention to Treat Epilepsy
Early Surgical Intervention to Treat Epilepsy
For Condition: Epilepsy, Temporal Lobe,Seizures,Epilepsy
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry 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.
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
JeromeEngel, Principal Investigator, UCLA School of Medicine, Department of Neurology
Bayfront Medical Center *Recruiting*
St. Petersburg, Florida, 33701
United States
Recruiting Michele Richardson 727-824-7135
University of New Mexico *Recruiting*
Albuquerque, New Mexico, 97131
United States
Recruiting Mona Chaney 505-272-3199
Swedish Medical Center *Recruiting*
Seattle, Washington, 98122
United States
Recruiting Erin Lystad 206-215-3565
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Lisa Daly 617-726-3311
Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Jeanne Toguri 312-695-0632
University of Rochester, Department of Neurology *Recruiting*
Rochester, New York, 14642
United States
Recruiting Geraldine Powers 585-275-0589
Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Sandra Clements 404-778-5907
Stanford University Medical Center *Recruiting*
Stanford, California, 94305-5235
United States
Recruiting Mimi Callanan 650-725-6648
Washington Unviersity *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Kathleen Johnson 314-362-7894
Barrow Neurological Institute *Recruiting*
Phoenix, Arizona, 85013
United States
Recruiting Nicole Hank 602-406-6251
Vanderbilt University *Recruiting*
Nashville, Tennessee, 37212
United States
Recruiting Diana Coleman 615-936-2027
UCLA School of Medicine, Department of Neurology *Recruiting*
Los Angeles, California, 90095-1769
United States
Recruiting Sandra Dewar 310-794-9528
Thomas Jefferson University Hospital *Recruiting*
Philadelphia, Pennsylvania, 19107
United States
Recruiting Carrie Comer 215-955-2606
MINCEP Epilepsy Care *Recruiting*
Minneapolis, Minnesota, 55416
United States
Recruiting Linda Chapeau 952-525-4939
John Hopkins University *Recruiting*
Baltimore, Maryland, 21287
United States
Recruiting Akemi Miller 410-955-2821
UT Southwestern Medical Center, Department of Neurology *Recruiting*
Dallas, Texas, 75390-9036
United States
Recruiting Diane Veath 214-648-6880
Cleveland Clinic *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Tracy Shenk 216-444-8638
Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Sylvia Done 212-305-1936
University of Michigan, Department of Neurology *Recruiting*
Ann Arbor, Michigan, 48109-0036
United States
Recruiting Lisa Szafran 734-936-9010
Additional Information:
Study ID Numbers: R01NS42372;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040326
Other Epilepsy, Temporal Lobe Studies:
1. Phenotype and Etiology of Pallister-Hall Syndrome
2. Study of Specimens Obtained during Epilepsy Surgery
3. Search for Genes Influencing Childhood Absence Epilepsy Study
4. Genetic Study of Familial Epilepsy
5. Multicenter trial for adults with partial seizures
Related Studies:
Other Epilepsy, Temporal Lobe Clinical Trials
Other Missouri Clinical Trials
Other St. Louis Clinical Trials
Early Surgical Intervention to Treat Epilepsy
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