100% Success Rate: All 32 Paralysis Patients in China’s Brain–Computer Interface Clinical Trial Achieve Brain-Controlled Grasping

On December 4, medical leaders from hospitals across China gathered at the NEO Wireless Minimally Invasive Implantable Brain–Computer Interface Multi-Center GCP Clinical Trial Summary Meeting, sharing their experiences with the NEO project, which had been performed on patients in each of their hospitals.

The NEO wireless minimally invasive BCI is the world’s first implantable BCI system using an epidural approach combined with fully wireless transmission. Since the first implantation at Xuanwu Hospital, Capital Medical University, on October 24, 2023, feasibility trials have been carried out at Tiantan Hospital, Huashan Hospital, Jiangsu Provincial People’s Hospital, and others—all showing strong clinical results. In August 2024, NEO entered the National Medical Products Administration’s special review channel for innovative medical devices, paving the way for full clinical registration trials.

In May 2025, the national multi-center GCP registration clinical trial officially began. Led by Prof. Mao Ying (Huashan Hospital) and Prof. Zhao Guoguang (Xuanwu Hospital) as principal investigators, trial centers across the country successfully implanted NEO in 32 patients with cervical spinal cord injury–induced paralysis.

The system’s core breakthrough lies in its coin-sized implant and fully wireless design. “NEO achieves low invasiveness, high reliability, and strong algorithm performance,” said Liu Tao, VP of BrainCo Medical Technology (Shanghai). “Through multi-layer noise reduction—from signal source to amplifier to algorithm—we achieved microvolt-level EEG ‘noise breakthrough’ even under extremely harsh electromagnetic conditions, enabling robust neural signal acquisition and decoding.” The implant uses a hermetically sealed titanium casing, validated through accelerated aging to maintain stable performance for over 20 years inside the human body.

With clinical data maturing, the NEO system will soon submit its Class III medical device registration application, positioning it to become one of the world’s first implantable BCI devices to enter regulatory review—a major step in strengthening China’s global leadership in this field.

All 32 patients achieved at-home brain-controlled grasping assistance and rehabilitation training, reaching 100% success on the primary clinical endpoints. Across all participants, cumulative post-implantation days exceeded 4,951 days, with no device-related adverse events, no serious device-related adverse events, and no device defects—demonstrating both the safety and long-term feasibility of the epidural minimally invasive implantation pathway.

Patients’ grasping scores on the internationally used ARAT (Action Research Arm Test) improved by an average of 8–9 points. Remarkably, even without wearing the BCI, patients showed a 10.71-point improvement in total upper-limb function, suggesting the technology’s potential to go beyond functional compensation and contribute to neurological recovery and functional reorganization.