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November12, 2001


Vagus Nerve Stimulation Proves to be an Effective Treatment in Children with Difficult-to-Treat Epilepsy

New study results show that an implantable device, called the vagus nerve stimulator (VNS), can help reduce seizure frequency and improve quality of life in children with treatment-resistant epilepsy. The results are published in this month's edition of the Journal of Child Neurology.

"This is a very promising therapy for children with medically refractory epilepsy," according to Sandra Helmers, M.D., associate professor of neurology, Emory University School of Medicine and principal investigator of the one-year trial. Medically refractory epilepsy is described as a condition that, despite adequate medical therapy, cannot be controlled. "Through this study, we found that VNS therapy is safe, well tolerated and highly effective in reducing seizure frequency over time in these children," Dr. Helmers reports. "Six months after the VNS was implanted, seizures were reduced in the average participant by nearly 45 percent."

Six centers in the United States enrolled 125 participants in the study. All received the vagus nerve stimulator implant. This is the largest group of children to receive the VNS in a study. The age of participants ranged from three to 18. About one-third of the participants were younger than 12 years of age. The typical participant, aged 12 years, started having seizures at the age of two and had already tried nine anti-epileptic drugs before turning to VNS therapy. "Uncontrolled seizures can put children at a greater risk of brain damage and increased mortality," Dr. Helmers explains. "Evaluating effective seizure control treatments such as VNS earlier, rather than later, may help children avoid these negative outcomes."

Treatment with VNS therapy not only resulted in a decrease in seizure frequency, but also in a striking improvement in various aspects of quality of life. Participants in this study were re-examined at three and six months following implantation. At those times, improvements were reported in alertness, verbal communication, school performance, clustering of seizures and post-seizure periods.

The vagus nerve stimulator, similar to a cardiac pacemaker, is implanted just under the skin in the left chest area. It stimulates the left vagus nerve in the neck through pre-programmed, mild, intermittent electrical pulses 24 hours a day. The implantation procedure takes approximately one hour and usually requires no overnight hospitalization. The device is manufactured by Cyberonics out of Houston, Texas. In 1997, the Food and Drug Administration (FDA) approved use of the VNS for patients, 12 years of age and older, with partial seizures. Partial seizures only affect one side of the brain.

Epilepsy is a chronic neurological disorder characterized by recurrent, unprovoked seizures. Nearly 2.3 million Americans are affected by the condition, including approximately 422,000 children aged 18 years and younger.

Dr. Helmers lead the six-center study, funded by Cyberonics, during her tenure at Children's Hospital in Boston, Harvard Medical School. That hospital, along with University of Texas Medical School in Houston, Minnesota Epilepsy Group, The Children's Hospital in Denver, Children's National Medical Center and Louisiana State University Comprehensive Epilepsy Center, were the six centers participating in this trial. Dr. Helmers now works in the Department of Neurology at Emory University School of Medicine, specializing in epileptic treatments in children and adults.


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