Tianjin University-driven project advances noninvasive BCI research

Résumé détaillé

A Tianjin University-led project has completed the first clinical research filing for a noninvasive brain-computer interface (BCI) under China's new biomedical regulations, giving…

A Tianjin University-led project has completed the first clinical research filing for a noninvasive brain-computer interface (BCI) under China's new biomedical regulations, giving researchers a formal route to test the technology in patients as Chinese companies seek to develop commercial applications.

The filing was completed with the National Health Commission on Nov 5, the university said.

The system combines a noninvasive BCI, spinal cord stimulation and a powered exoskeleton to help stroke patients regain movement in their legs. Developed by the university's Haihe Laboratory of Brain-Computer Interaction and Human-Machine Integration, it detects brain signals associated with a patient's intention to move, then coordinates electrical stimulation and the exoskeleton to assist walking.

Researchers aim to help patients recover motor function, rather than rely solely on mechanical assistance. The study will examine safety and feasibility in people whose recovery has stalled after conventional rehabilitation. Its clinical benefits have yet to be established.

The filing does not amount to approval for commercial use. It comes after regulations governing clinical research and the application of new biomedical technologies took effect in May. The rules require scientific and ethical reviews and set out procedures for testing experimental treatments in patients.

Ming Dong, vice-president of Tianjin University and director of the laboratory, said researchers would follow the filed study protocol and refine rehabilitation plans for individual patients.

Hao Fei, a lecturer at the International Business School of the University of International Business and Economics, said the filing was significant because it brought the technology into a more standardized clinical research process.

China is also pursuing implantable BCI technology. In March, the National Medical Products Administration approved a device developed by Shanghai-based Neuracle Technology that helps people with…

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