Academician Wang Yongjun Advocates Clinical-Need-Driven and Safety-Based Brain-Computer Interface Trials

Source: Shanghai Securities News · China Securities Network

Shanghai Securities News China Securities Network (Reporters: Zhong Qian, Yan Ximeng) What is the current status of clinical trials for global brain-computer interface (BCI) technologies and products? How are the clinical trials for Neuralink’s implantable BCI progressing in the United States? How is China’s BCI industry advancing clinical trials? On May 10, at the 2026 National Conference on the Integration and Innovation of Brain-Computer Interface Technology and Industry, Wang Yongjun, Academician of the Chinese Academy of Sciences and President of Beijing Tiantan Hospital Affiliated to Capital Medical University, delivered a keynote speech. He shared insights and provided recommendations on how the BCI industry should view and address issues related to clinical trials.

Wang Yongjun stated that, based on the current status of global clinical trials for implantable brain-computer interfaces (BCIs), the industry as a whole is in an early exploratory phase, with the United States, Australia, and China serving as core research regions. Among these, the United States, led by companies such as Neuralink and Synchron, has seen the most rapid progress in clinical trials; Australia hosts Synchron’s clinical sites, focusing on the clinical validation of related technologies; while China, centered around research institutions such as Zhejiang University and the Shanghai Brain Science Center, is gradually advancing clinical trials of domestically developed BCI technologies.

“Based on currently available global clinical trial data for brain-computer interfaces (BCIs), BCI technology, as the core mechanism linking the brain with external devices, holds promise for providing novel solutions to help individuals with severe disabilities regain functional independence.” Citing Neuralink as an example, Wang Yongjun introduced the company’s four core clinical trial portfolios, which cover the domains of motor function, speech, activities of daily living, and vision. All trials have achieved phased breakthroughs while strictly adhering to unified clinical design principles to ensure technological safety and reliability. For instance, Neuralink has initially launched the PRIME Study in the field of motor function reconstruction, primarily targeting patients with quadriplegia due to cervical spinal cord injury and those with amyotrophic lateral sclerosis (ALS). “To date, the trial has successfully completed implantations in 21 patients, yielding significant core outcomes: patients’ thought-controlled typing speeds reach 22–35 characters per minute, sufficient to meet basic daily communication needs; furthermore, average weekly device usage exceeds 50 hours, fully demonstrating the practicality and stability of the system.”

In the VOICE Study clinical trial, Neuralink focused on patients with severe aphasia and locked-in syndrome, including those in the late stages of ALS and individuals who had suffered brainstem strokes—populations unable to communicate through conventional methods—providing them with a new avenue to restore communicative abilities. “The core of this technology involves implanting a customized N1 Speech electrode array into the patient’s speech motor cortex, leveraging AI technology to decode brain signals in real time and convert them into recognizable speech, thereby enabling thought-to-speech communication,” introduced Wang Yongjun. Clinical trials for this type of technology were initiated earlier this year, and trial reports indicated that the first patient achieved a thought-based spelling accuracy rate of 96.7% within one week post-surgery, far exceeding the expected targets.

However, data indicate that the vast majority of relevant clinical trials worldwide are currently in the early feasibility study phase (Phase I/II), with sample sizes typically ranging from 10 to 100 participants. Core assessment metrics focus primarily on safety and functionality, including the incidence of complications, serious adverse events, information transmission rates, and control accuracy. “At present, safety and clinical efficacy remain the core challenges facing the industry. It is recommended that R&D professionals in China’s brain-computer interface (BCI) sector collaborate closely with healthcare providers to develop clear clinical trial protocols. These should be guided by clinical needs, grounded in technological safety, and emphasize both scientific rigor and humanistic care,” introduced Wang Yongjun. He noted that certain best practices could be promoted, such as: omitting blank control groups in trials and prioritizing patient safety as the primary evaluation criterion to maximize the protection of patients’ rights and interests; adhering to long-term follow-up with a duration of at least 12 months; implementing AI-based closed-loop validation to compensate for signal drift in real time and ensure long-term system stability; and ensuring end-to-end compliance by strictly adhering to FDA regulations on medical device cybersecurity and data encryption to safeguard patient privacy.