First Public Results of the SANTE Trial Announced at AES

Saturday night Robert Fisher, MD, professor of neurology and director of the Stanford Epilepsy Center, presented the first public results of the stimulation of the anterior nucleus of the thalamus in epilepsy (SANTE). There were 110 patients between ages 18-65 years who participated in the study with locations found nationwide, with extremely positive results reported. Researchers saw a significant improvement in seizure control during double-blind, open-label, and long-term follow up phases. During the double-blind phase one patient became seizure free, tow patients in open-label, and nine in long-term follow up. Among all patients, there was a 19% significant decrease in the number of seizures. Fisher also said that they found significant seizure control improvements in patients with severe seizure types. These results will enable Medtronic to seek FDA approval to sell the device.

Some of the key highlights from the study include:

• 53 patients using the device in conjunction with epilepsy medications saw a median reduction in seizure frequency of 38 percent at three months
• 60 percent of study participants for whom researchers had long-term data reported a 50 percent or greater reduction in their baseline rate of seizures at the end of the study period—anywhere from one to four years.

In the end, the study’s objective was met of having a 30% media improvement—there was a 63% median reduction of seizures (1 in 5 patients had a 90% seizure reduction!). Additionally, Fisher stressed how this is the first large enrollment trial to test deep brain stimulation for epilepsy that has been completed.

This study features extremely positive results, but like all others there were some adverse events. However, during the presentation Fisher said, “There aren’t enough to go on and on about.”

One of the last things Fisher said was that since the device has proven to work, “we need to figure out how it can be made better.”