DEMONSTRATION OF IMPLANTED  EPILCURE™.  

Epilcure™, country's first closed loop neurostimulation system developed by Prof. ZHANG Jianmin, Chair of SAHZU Neurosurgery, Prof. ZHU Junmin, Vice Chair of SAHZU Neurosurgery, and their team, is proved to be effective after one month's follow-up since its first implantation on March 18. This breakthrough, based on the Brain-Computer Interface (BCI) research that has long been carried out by Prof. ZHANG and Prof. ZHU's team, marks a milestone for the treatment of refractory epilepsy.

The closed-loop neurostimulation system is a therapeutic device implanted under patient's skull to provide neurophysiological diagnosis and neurostimulation therapy, especially for refractory epilepsy control. As a novel technology of neuromodulation therapy, the closed-loop neurostimulation system does not require an open surgery as opposed to traditional epilepsy procedures, and could be applied to inoperable clinical conditions such as bilateral hippocampal sclerosis.

Compared with other neuromodulation therapies, the most featured function of the system is the accuracy of its on-demand stimulation in a closed-loop manner. The device could deliver accurate stimulation with immediate detection of the beginnings of seizure attacks or even before the attacks, when monitoring patient’s brain electrical activity specific to epilepsy or other diseases. In this way, this system is thought to have a good performance in the control of epilepsy or other conditions.

Epilcure™ system is a small and light device of estimated 10-year service life. A weekly 10-20 minutes charging is sufficient to sustain its function. The charging steps are as simple as wearing the charging device on the arm and putting on a Bluetooth configured head cover.

MS ZHOU AND HER EPILCURE™

According to reports, there is only one FDA-approved closed-loop neurostimulation in the world, Neuropace RNS® System, which however has not entered China yet. The reality is that patients with refractory epilepsy in China or even the entire Asia have no access to this novel therapy.

BCI research team of SAHZU, led by Prof. Zhang and Prof. Zhu, began exploring the clinical application of closed-loop neurostimulation since 2010. Sponsored by national and provincial fundings, the team knuckled down to the clinical translation of its research work, and finally developed the Epilcure™ system in collaboration with a Hangzhou-based medical technology company.

The patient who underwent the first implantation is 33-year-old Ms. Zhou, diagnosed for epilepsy for 19 years. Before the procedure, 20 to 30 seizures every month with hands cramps and numbness unresponsive to medication control, greatly affected her life quality. She was further diagnosed for refractory epilepsy with inoperable bilateral hippocampal sclerosis by SAHZU neurosurgeons, who then designed a tailored treatment plan for Ms. Zhou that centered around the implantation of Epilcure™ closed-loop neurostimulation system. The second day after the procedure, Ms. Zhou could get out of the bed; in the following month, the device successfully delivered neurostimulation after detecting brain electricity activity of beginnings of seizures, and prevented several epileptic seizures from happening. Ms. Zhou so far has not presented any epileptic convulsions.

The Epilcure™ system is not merely an outcome of SAHZU BCI team's 10-year research work, its success also marks a new beginning of future application of closed-loop neurostimulation. The team will keep following up with the postoperative efficacy. On the other hand, the team is planning to launch a multicenter clinical trial about the device.