China's first 128-channel fully implantable BCI system initiates a multi-center clinical trial at Beijing Tiantan Hospital, enrolling 32 patients with severe motor impairment.
• 128-channel fully implantable BCI — China's first ultra-high-channel-count invasive BCI
• Multi-center trial — led by Beijing Tiantan Hospital with 32 patients
Severe motor impairment — targeting patients with paralysis and locked-in syndrome
• Next-generation neural recording — offering unprecedented signal resolution
Introduction
Brain-computer interfaces (BCIs) have emerged as one of the most promising technologies for restoring function in patients with severe motor impairment. While early BCI systems demonstrated proof-of-concept, they were limited by the number of recording channels, signal quality, and device longevity.
In 2026, a team from Beijing Tiantan Hospital announced the initiation of a multi-center clinical trial for a 128-channel fully implantable BCI system — the first such system developed in China and one of the most advanced BCI devices globally.
This trial represents a significant advancement over previous BCI systems, which typically offered 16–64 channels. The 128-channel system provides substantially higher spatial resolution, enabling more precise decoding of neural signals and more accurate control of external devices.
System Overview
The 128-channel BCI system is a fully implantable, wireless, high-density neural recording device designed for long-term use in patients with severe motor impairment.
Key features:
- 128 recording channels — offering high spatial resolution for decoding complex neural signals
- Fully implantable — eliminating the need for transcutaneous wires and reducing infection risk
- Wireless data transmission — enabling real-time signal processing and device control
- Long-term stability — designed for years of continuous operation
- Compatible with multiple decoding algorithms — supporting both motor and communication applications
Clinical Trial Design
The multi-center clinical trial is being conducted at Beijing Tiantan Hospital with additional participating centers across China.
| Parameter | Details |
|---|---|
| Lead Institution | Beijing Tiantan Hospital |
| Number of patients | 32 patients with severe motor impairment |
| Patient population | Spinal cord injury, ALS, stroke, and locked-in syndrome |
| Primary endpoint | Safety and device performance at 12 months |
| Secondary endpoints | Functional improvement, quality of life, signal stability |
Patient Population
The trial enrolls patients with severe motor impairment who have limited or no functional movement. Eligible conditions include:
- Spinal cord injury (C1–C5 level, ASIA A or B)
- Amyotrophic lateral sclerosis (ALS) — advanced stages with limited upper limb function
- Stroke — with severe hemiplegia and no functional recovery
- Locked-in syndrome — complete paralysis with preserved cognition
Implant Procedure
The implantation procedure involves a craniotomy to place the 128-channel microelectrode array on the cortical surface. The device is positioned in the motor cortex, the region responsible for voluntary movement planning and execution.
The device is connected to a subcutaneous wireless transmitter, which relays neural signals to an external processing unit. Patients undergo a training period during which they learn to modulate their neural activity to control external devices.
Expected Outcomes
The trial aims to demonstrate:
- Safety — no serious adverse events related to the implant
- Device performance — stable signal recording over 12 months
- Functional improvement — patients able to control external devices such as robotic arms, computer cursors, and communication interfaces
- Quality of life — significant improvement in patient-reported outcomes
Significance for Chinese Neurotechnology
This trial represents a major milestone for Chinese neurotechnology:
- First 128-channel BCI in China — demonstrating advanced neural recording capabilities
- Multi-center collaboration — establishing a national framework for BCI clinical research
- Global competitiveness — positioning China alongside the U.S. and EU in advanced BCI development
- Path to commercialization — building the evidence base for regulatory approval
Future Directions
Following the successful completion of this trial, the research team plans to:
- Expand to larger patient cohorts in future studies
- Explore applications in communication and environmental control
- Develop next-generation devices with even higher channel counts
- Investigate combination therapies with neurostimulation