Application — Cortical surface
NEO implantable wireless BCI tetraplegia trials and NMPA registration (NCT06990412, NCT05920174)
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Neuracle · NEO · Tsinghua · epidural · tetraplegia · NMPA · registration trial
NEO tetraplegia trials and NMPA registration (NCT06990412, NCT05920174)
The clinical program behind the NEO wireless epidural BCI (Neural Electronic Opportunity), developed by Neuracle from Tsinghua’s design: a completed 32-patient multicenter registration trial in tetraplegia, followed by China’s NMPA approval, with an earlier feasibility trial still listed as recruiting. Registry facts are from ClinicalTrials.gov (verified October 29, 2026). The approval and the outcome figures circulating with it come from institutional news and media reports, not a peer-reviewed results paper, and are labeled as such.
Registration trial facts (NCT06990412)
| Field | Value and source scope |
|---|
| Registry | NCT06990412; interventional, single-group, no masking; purpose stated as providing a basis for product registration [1] |
| Sponsor | Neuracle Medical Technology (Shanghai) Co., Ltd., with 12 collaborating hospitals including Huashan (Fudan), Xuanwu, Tiantan and West China [1] |
| Status | Completed [1] |
| Dates | Actual start May 28, 2025; actual primary completion November 6, 2025; actual completion January 10, 2026 [1] |
| Enrollment | 32 (actual) [1] |
| Population | Tetraplegia; spinal cord injury [1] |
| Primary outcomes | BCI-assisted ARAT (Action Research Arm Test) grasp response rate at 3 months post-operation; adverse events through 6 months [1] |
| Secondary outcomes | ISNCSCI neurological scores; ARAT scores with the device on and off; investigator’s overall device performance evaluation [1] |
Earlier feasibility trial (NCT05920174)
| Field | Value and source scope |
|---|
| Registry | NCT05920174; prospective, single-group, no masking [2] |
| Sponsor and sites | Neuracle; PLA General Hospital, Xuanwu, Tiantan (Beijing) and Huashan (Shanghai) [2] |
| Status and dates | Listed as recruiting; actual start October 17, 2023; estimated completion December 2025 [2] |
| Enrollment | 9 (estimated) [2] |
| Outcomes | Adverse events (12 months); BCI classification accuracy and bit rate; monthly hours of NEO use; patient/caregiver satisfaction (3, 6, 12 months) [2] |
Reported outcome and approval
| Field | Value and source scope |
|---|
| Approval | China’s National Medical Products Administration approved the NEO registration application, described by the trial’s lead hospital as the world’s first implantable BCI Class III medical device to receive market approval (institutional news) [3]; independently covered as the first invasive BCI approval (technology press) [4] |
| Validation scope | 32 clinical-validation cases completed across 12 medical institutions, led by Huashan Hospital, Fudan University [3] |
| Patient case | One Huashan participant, a 40-year-old man six years after a cervical spinal cord injury, was implanted in November 2024, used the BCI with pneumatic gloves, lifted a cup after one month, and wrote unassisted after the device was later removed (institutional account) [3] |
| Evidence gap | No peer-reviewed results paper for the registration trial identified as of October 29, 2026; the grasp-function improvement figures cited publicly come from trial leads’ press accounts [3][4] |
Primary sources
- ClinicalTrials.gov, NCT06990412. Verified October 29, 2026.
- ClinicalTrials.gov, NCT05920174. Verified October 29, 2026.
- Fudan University news, World’s First BCI for Hand Movement Approved in China, March 17, 2026. Institutional news from the trial’s lead hospital.
- MIT Technology Review, China has approved the world’s first invasive brain-computer chip, June 1, 2026. Media report.