Children as young as age 4 are now eligible for vagus nerve stimulation (VNS) therapy, according to new guidelines released by the Food and Drug Administration (FDA) this summer. Previous guidelines approved the device for children ages 12 and older.
Neuroscience Institute Co-director James Wheless, MD, has been part of extensive research examining the safety and effectiveness of VNS devices in young children in the last 22 years. It is estimated that one out of every three VNS devices is implanted in children and adolescents younger than 21 years old. This accumulated experience, along with recent studies, led to the formal FDA approval for children. Recent work found that 48 percent of young children had a reduction in seizure duration; 42 percent had a reduction in severity; and 40 percent showed a reduction in post-ictal severity.
“There has been much work in the last 10 plus years convincing the FDA that a partial seizure in a 4-year-old has the same underlying mechanism as it does in an adult and adolescent,” said Wheless.
The device has been life-changing for 10-year-old Oliver Prats of Baton Rouge, La. Before he received a VNS in November 2015, seizures were ruling his life, said his mom, Lacey.
Diagnosed with epilepsy at 6 months old, Oliver’s seizures became more frequent and more severe by his fifth birthday. He was on three medications that yielded little control of his seizures.
“He wasn’t learning and was having anger outbursts. We had lost him to seizures,” Lacey said.
The Prats family was referred to Wheless in 2015. When Wheless suggested a VNS device, the family was hesitant. When new medications and diet changes produced little success, the Prats finally agreed to proceed with the surgery.
Today, Oliver is 15 months seizure-free. He was able to transfer from his special needs school and is thriving, says Lacey.
“He’s back to his happy, go-lucky self. It’s the best decision we’ve ever made and has completely changed our lives,” said Lacey.
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