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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-825 | Other Identifier | Huashan Hospital Institutional Review Board of Fudan University |
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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implantation of the WRS | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WRS | Device | WRS is a minimally invasive, wireless brain-machine interface system |
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| Measure | Description | Time Frame |
|---|---|---|
| success rate of brain-controlled tasks | The success rate of brain-controlled tasks is defined as the proportion of trial participants who successfully complete the brain-control task | 3 months post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| success rate of brain-controlled tasks | The success rate of brain-controlled tasks is defined as the proportion of trial participants who successfully complete the brain-control | 6 months post-operation |
| Brain Control Fluency Index |
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Inclusion Criteria:
(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 participants must agree to use effective contraception throughout the trial period; 5. Participants, either independently or with caregiver assistance, are willing to follow investigators' guidance, comply with all procedures stipulated in the study protocol and complete all scheduled trial visits as required; 6. Having normal cognitive function with a Mini-Mental State Examination (MMSE) score ≥20 points (excluding three-step commands, writing and drawing items); 7. Elbow flexor muscle strength ≤ Grade 3 assessed by ISNCSCI scale; 8. Being of good compliance, voluntarily participating in the clinical trial and signing the informed consent form.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical team Stairmed | Contact | +86 021-80510178 | yumiao@stairmed.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| up to 180 days |
| Task Accuracy | up to 180 days |
| Device Reliability | up to 180 days |
| Device Usage Duration | up to 180 days |
| Evaluation of Brain-Controlled Wheelchair | 3 and 6 months post-operation |
| WHOQOL-BREF | 3 and 6 months post-operation |
| dIADL | 3 and 6 months post-operation |
| HADS-A | 3 and 6 months post-operation |
| PHQ-9 | 3 and 6 months post-operation |
| D014947 | Wounds and Injuries |