China's Neuracle Registers 96-Patient Trial of Closed-Loop Epilepsy Implant
Chinese registry ChiCTR2400081380 describes a 96-patient trial of an implantable closed-loop recording and stimulation system for focal drug-resistant epilepsy in people aged 6 to 70. All participants are to receive the implant and then be randomized one month later to active or sham stimulation, 48 per group. The registry provides no evidence that enrollment had passed 50%.
Why it matters
The sham-controlled design tests sensing, seizure detection and closed-loop stimulation as one therapeutic system, producing evidence closer to registration needs than an electrode-monitoring study.