The results demonstrate that, instead of being considered a last resort, early surgery could help epilepsy patients avoid decades of disability.
“The results of this study are very clear: early surgical intervention works, it stops seizures, and it improves quality of life,” said University of Rochester Medical Center (URMC) neurologist Karl Kieburtz, M.D., the senior author of the study. “Individuals with temporal lobe epilepsy that is not controlled with medicine should be evaluated for surgical intervention at a comprehensive epilepsy center not after decades of poor response to medicine but within two years. And if they are a surgical candidate they should give strong consideration to that approach.”
Temporal lobe epilepsy is the most common drug resistant form of epilepsy. The source of the seizures, which can be chronic and debilitating, is one of the temporal lobe regions which reside on either side, or hemisphere, of the brain.
While surgical treatment has been shown to be effective in reducing seizures, the procedure – which is called a temporal lobectomy and entails removing a part of the temporal lobe – is often only considered after all other medical options have failed. Consequently, patients referred for surgery have been living with the condition for an average of 22 years and are often 10 years removed from having been declared “refractory,” meaning that that at least two different antiepileptic drugs have failed to control their seizures. As a result, by the time patients opt for surgery they have often been living at high level of disability with a loss of independence and diminished quality of life for an extended period of time.
The study – which is called the early randomized surgical epilepsy trail (ERSET) – was designed to evaluate whether early surgical intervention would not only effectively control seizures but also improve quality of life, and whether or not these benefits would be outweighed by side effects of the surgery, such as a decline in cognitive function.
The multi-center study followed individuals with mesial temporal lobe epilepsy. In order to be eligible, patients had to be within two years of having been declared refractory. One group of participants underwent a temporal lobectomy and the other group was assigned to a program of best medical care.
The study then tracked the frequency and severity of the participant’s seizures, their cognitive function, quality of life, social interactions, and other outcomes such as employment and education status, ability to work, and number of hospitalizations over a 24 month period.
The study found that after two years, 73 percent of the participants who underwent surgery were seizure free in the second year after the procedure as opposed to none in the medical group. The surgical group also reported a significantly higher quality of life. Cognitive problems such as memory loss were similar between both groups. The members of the surgical group also reported a significant increase in independence and the willingness and ability to spend more time with friends and family. For example, the number of individuals who reported being able to drive a car rose from 7 to 80 percent in the surgical group. At the end of two years, only 22 percent of the medical group was driving.
“The results of this study are very encouraging,” said Jerome Engel, Jr., M.D., Ph.D., a neurologist at the University of California Los Angeles and lead author of the study. “Surgical treatment for temporal lobe epilepsy soon after the failure of two trials of anti-epileptic drugs stops seizures and improves quality of life. Continuing anti-epileptic drug treatment alone does not.”
The results were a surprise given that the study had been recommended for early termination due to slow enrollment. The study was originally intended to follow 200 patients, but only 38 were ultimately recruited. Despite the low number of participants, the results are statistically significant enough to – in the authors’ opinion – compel a new approach to the treatment of patients with uncontrolled temporal lobe epilepsy.
“The delay between people becoming refractory and eventually having surgery explored as an option is unacceptable,” said Giuseppe Erba, M.D., a neurologist with the Strong Epilepsy Center and a co-author of the study. “People with temporal lobe epilepsy need to be referred and evaluated for this therapy earlier and before they develop chronic disability.”
Additional co-authors of the study include Michael P. McDermott, Ph.D., John Langfitt, Ph.D., and Irenita Gardiner, R.N. with URMC, Jerome Engel, M.D., Ph.D., John Stern, M.D., Itzhak Fried, M.D., Ph.D., and Harry Vinters, M.D. with the University of California Los Angeles, Scott Mintzer, M.D. with Jefferson University, and Samuel Wiebe, M.D. with the University of Calgary. URMC’s Center for Human Experimental Therapy (CHET) served as the coordinating center for the study. Kieburtz is the director of CHET. The study was funded by the National Institute of Neurological Disorders and Stroke.
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