Clinical Translation

Guangdong issued a provincial BCI action plan targeting 100 new tech companies, 200 BCI hospital wards and a ten-billion-yuan industry by 2030.

Neuracle Medical Technology (Shanghai) Co., Ltd. registered the Implantable Brain-Computer Interface Hand Motor Function Compensation System in the NMPA Medical Device Unique Identification database. Its model is NEO-M Pro, and its registration certificate number is 国械注准20263120537. The description lists a BCI implant, an implantable EEG electrode kit, a disposable surgical tool kit, an EEG signal transceiver, a pneumatic glove device, and three software products, each with release version 1.0. The entry provides product identification and composition information; UDI registration itself should not be interpreted as validation of clinical efficacy or safety.

Neuracle registered the NEO-M Implantable Brain-Computer Interface Hand Motor Function Compensation System in the NMPA Medical Device Unique Identification database. Its registration certificate number is 国械注准20263120537. According to the company's description, the system includes a BCI implant, an implantable EEG electrode kit, a disposable surgical tool kit, an EEG signal transceiver, a pneumatic glove device, and EEG decoding, medical testing, and clinical management software. All three software products have release version 1.0. The entry identifies the product and its components; UDI registration itself does not validate clinical efficacy or safety.

The Chinese Clinical Trial Registry (ChiCTR) logged a new study on June 5, 2026 under the number ChiCTR2600126291, testing whether a period of multisensory embodied training beforehand alters the neural representation of imagined movement and the decoding performance of a brain-computer interface (BCI). Recruitment has not yet begun.

The randomized controlled trial plans to enroll 58 patients with upper limb motor dysfunction after stroke. The test group will receive feedback-based rehabilitation training through brain-computer interface interaction, while the control group will undergo traditional upper limb circular motion training. The primary outcome is the Fugl-Meyer Motor Assessment-Upper Extremity (FMA-UE), with secondary outcomes covering motor function, daily living activities, quality of life and neurophysiological measures including EEG, transcranial magnetic stimulation and fNIRS. The trial was prospectively registered, with first enrolment set for June 1, 2026, and recruitment has not yet started.

The multicenter randomized controlled trial plans to enroll 222 patients who are 1 to 3 months past their first stroke and have motor impairment in the affected lower limb. The experimental group will receive 4 weeks of motor imagery-based BCI-driven active and passive lower limb training, while the control group gets 4 weeks of conventional training. The primary outcome is the Fugl-Meyer Assessment Lower Extremity Section, with balance, daily living ability and walking classification as secondary outcomes. First enrolment is set for May 31, 2026.

The Jiangxi Provincial Health Commission in eastern China issued Guidelines for Ethics Review of Brain-Computer Interface Clinical Research Projects on May 26, 2026, document number Gan Wei Ke Jiao Fa [2026] No. 8, providing implementing detail for the mutual recognition mechanism proposed in the province's November 2025 BCI measures. For multicentre projects the lead institution's ethics committee conducts the first full review; participating institutions should finish within 10 working days of receiving complete materials and examine only local research conditions, staff qualifications and the informed-consent process; and the lead institution must file with the provincial medical ethics expert committee within 10 working days. Invasive projects treating neurological or psychiatric disease need provincial committee review within 20 working days, with an opinion issued within a further seven.

A Chinese team has registered a clinical trial of a multimodal brain-computer interface system for intelligent diagnosis and treatment, aimed at early screening and non-invasive modulation of Alzheimer's disease. The entry, ChiCTR2600125240, was filed with the Chinese Clinical Trial Registry on May 22, 2026 and is carried by the WHO International Clinical Trials Registry Platform; recruitment has not begun.

The trial tests whether a steady-state visual evoked potential (SSVEP) brain-computer interface can drive functional electrical stimulation of swallowing muscles more effectively than conventional neuromuscular electrical stimulation. It plans to enroll 90 patients, 45 per arm, all within 6 months of a first ischemic or hemorrhagic stroke and aged 18 to 80. The primary outcome is the Standard Swallowing Assessment, with secondary measures including the Functional Oral Intake Scale and the Penetration-Aspiration Scale. First enrollment is listed for June 1, 2026.

Burning mouth syndrome produces months or years of burning oral pain with no visible lesion on examination, and treatment options are limited, leaving patients shuttling between oral medicine and psychiatry. A randomized, sham-controlled interventional trial registered by Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine, will apply transcranial direct current stimulation over the left dorsolateral prefrontal cortex while collecting resting-state brain function and structural imaging, tracking pain, anxiety, depression, sleep and salivary flow. The trial is funded by the hospital's Brain-Computer Interface Special Research Program and registered as ChiCTR2600124987 on May 20, 2026. It plans to enroll 38 participants, 19 in the active group and 19 in the sham group, with first enrollment set for June 1, 2026; recruitment has not yet started.

The trial plans to enroll 40 patients with Parkinson's disease aged 40 to 80, randomized into 2 groups: one adds brain-computer interface rehabilitation training to functional electrical stimulation, the other receives functional electrical stimulation alone. Both arms train 20 minutes per day for the upper extremities and 20 minutes per day for the lower extremities, completing 12 treatment days within 2 weeks. The primary endpoint is a motor symptom rating scale, with diffusion tensor imaging, magnetic resonance spectroscopy, resting-state fMRI, and sleep, cognitive and mood scales as secondary endpoints, testing whether adding BCI training produces measurable change beyond motor symptoms.

A trial testing a brain-computer interface (BCI) combined with transcranial direct current stimulation (tDCS) in patients with disorders of consciousness was registered with the Chinese Clinical Trial Registry (ChiCTR) on May 7, 2026 under the number ChiCTR2600124127, and is now recruiting. The design, sample size and sponsor are not given in the record and would have to be checked against the original registration.

A randomized, sham-controlled trial will pair a non-invasive brain-computer interface with MRI-guided multichannel temporal interference stimulation in patients whose migraines resist medication. It plans to enroll 78 people aged 18 to 65, split evenly between real and sham stimulation, with headache frequency as the primary endpoint. The registration lists only design and bibliographic fields, so device details and actual enrollment remain unknown and efficacy has yet to be read out.

The Chinese Clinical Trial Registry (ChiCTR) has logged a study of the safety and efficacy of early brain-computer interface training given after reperfusion therapy in patients with acute ischemic stroke, an attempt to pin down when in the recovery window such training should start. Registered on April 27, 2026 as ChiCTR2600123548, the trial has not begun recruiting, and design, sample size and sponsor are absent from the record carried by the WHO International Clinical Trials Registry Platform (ICTRP) and must be read from the original registration.

A trial registered in China pairs brain-computer interface technology with mindfulness meditation training for adolescents with depression, recording EEG alongside the sessions to see how brain activity changes. The question is whether real-time brain signals can be read during meditation and fed back into the training, making the intervention more responsive to each participant's state. Recruitment has not yet started, and the design, sample size and sponsor have not been disclosed.

A new entry in the Chinese Clinical Trial Registry covers a study using brain-computer interface technology for functional recovery after stroke. The record, ChiCTR2600120924, was posted on March 23, 2026, and lists its status as not yet recruiting. The registry listing carries only bibliographic details, so the trial design, sample size and sponsor remain undisclosed.

The Chinese Clinical Trial Registry (ChiCTR) has logged a study of a brain-computer interface (BCI)-enabled cognitive rehabilitation system, set to test its clinical effect in patients with mild cognitive impairment. Registered on February 25, 2026 as ChiCTR2600119334, the trial is not yet recruiting.

Alphatec Spine's SafeOp 3 neural monitoring system received FDA 510(k) clearance on January 11, 2026 for intraoperative neural monitoring. The device is regulated as a Class II "Stimulator, Electrical, Evoked Response" under regulation number 882.1870, and the clearance came through the traditional 510(k) pathway, with the FDA finding the device substantially equivalent to a predicate device. Alphatec Spine, a maker of spinal surgery devices and technologies, adds SafeOp 3 to its neural monitoring portfolio; the system is intended to let surgeons assess nerve function in real time during procedures and lower the risk of nerve injury.

Tongji Hospital in Wuhan announced a brain-computer interface research institute on 5 September 2025, which it says is the first of its kind run by a hospital in China rather than by a university or a company. The institute covers basic research, clinical application and commercialisation, with the stated aim of building a full-chain BCI system spanning prevention, diagnosis, treatment and rehabilitation of neurological disease.

Shanghai's science commission issued a BCI industry action plan centering on medical-grade scenarios, with a clinical timeline for invasive and semi-invasive products.

Synchron reported 12-month results from the U.S. COMMAND early feasibility study in six people with severe chronic bilateral upper-limb paralysis. All participants met the primary safety endpoint of no device-related serious adverse event causing death or permanent increased disability, and motor-intent signals were converted into digital actions throughout the study. The disclosure was not a two-year pivotal-trial report.

The FDA issued final guidance in 2021 on implanted brain-computer interface (BCI) devices for patients with paralysis or amputation, covering nonclinical testing and clinical study design.

Vanderbilt University Medical Center has developed a method that uses post-operative CT scans and image processing to determine the physical relationship between cochlear implant electrodes and the neural interface, allowing sub-optimally positioned electrodes to be switched off for a customized map. Cochlear implants are surgically implanted devices that restore hearing by electrically stimulating the auditory nerve, and their programming has traditionally ignored where the electrodes actually sit. The trial tested whether this individualized image-guided programming improves hearing and speech outcomes in pediatric recipients, with hearing measures collected at baseline, 12 months and 24 months; it has been completed, but results have not been posted.