Neuracle NEO invasive BCI clinical trial results: epidural EEG-controlled glove improves hand function in chronic SCI
Summary
The clinical trial data supporting China's NMPA approval of the Neuracle NEO system, demonstrating that epidural brain-computer interface control of a pneumatic robotic glove improved hand motor function in cervical SCI patients who retained some upper arm movement. The study showed that participants could perform grasping movements — picking up objects, drinking water — using decoded brain signals to control the glove, with significant improvement in standardized hand function tests versus baseline.
Why it matters
The clinical trial data behind the world's first commercial BCI approval provides the scientific basis for a landmark regulatory decision. The epidural (non-penetrating) electrode approach achieving clinically meaningful hand function improvement demonstrates that a conservative, lower-risk implant strategy can produce real therapeutic benefit — an important precedent for global regulatory agencies.
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