Implantable Wireless Brain-Machine Interface System for Spinal Cord Injury: Efficacy and S
This is a prospective, open-label, multi-center, single-arm study to evaluate the efficacy and safety of an implantable wireless brain-machine interface (BMI) system in patients with spinal cord injury. Eligible participants will undergo screening after signing informed consent, followed by BMI system implantation. Fol
| Condition(s) | Spinal Cord Injury |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This is a prospective, open-label, multi-center, single-arm study to evaluate the efficacy and safety of an implantable wireless brain-machine interface (BMI) system in patients with spinal cord injury. Eligible participants will undergo screening after signing informed consent, followed by BMI system implantation. Follow-up visits will be conducted postoperatively to assess brain-control performance and safety. |
| Who can participate | Inclusion Criteria: 1. Aged 18 to 65 years old (inclusive), with no restriction on gender. 2. Meeting all the following requirements: (1) Suffering from complete or incomplete tetraplegia secondary to cervical spinal cord injury (C2-C6); (2) Diagnosed in line with the 2019 revised International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) issued by the American Spinal Injury Association (ASIA), with neurological injury grade classified as Grade A to Grade C; (3) Having fulfilled the above diagnostic criteria for no less than 12 months; 3. Confirmed by imaging examinations and neurological evaluations that the motor-related cerebral cortex is structurally intact, functionally normal and free of obvious atrophy, organic lesions or functional disorders; 4. Fertile |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Shanghai StairMed Technology Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2026-04-28 |
| NCT ID | NCT07603752 |
| Official listing | https://clinicaltrials.gov/study/NCT07603752 |