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This is an open-label single-arm clinical study conducted at designated clinical trial institutions, with three overall phases: a 3-month main study, a 3-month extension, and a 3-month follow-up. The main study includes screening/baseline, preoperative preparation, surgery, upper limb rehabilitation adjustment, and pneumatic hand function training-specifically, preoperative brain and spinal cord imaging for electrode placement in eligible subjects, implantation of high-channel electrodes, and postoperative combined rehabilitation to build a motor intention decoding model that drives the pneumatic hand to grasp. The extension phase focuses on precise assessment of upper limb grasping function, signal stability monitoring, implantation of epidural spinal cord test electrodes, and closed-loop regulated epidural electrical stimulation for limb rehabilitation using implanted intracranial electrode signals. The follow-up phase involves intracranial electrode removal, implantation of long-term epidural spinal cord electrodes, and limb rehabilitation training and observation based on scalp EEG signals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBCI | Experimental | Receive invasive BCI intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Invasive BCI | Other | Main Study Phase: Subjects undergo intracranial electrode implantation surgery. After surgery, motor intention decoding is performed on the electroencephalographic (EEG) signals recorded by the intracranial electrodes, and the decoded signals drive an external hand continuous passive motion device to achieve upper limb grasping movements. Extension Phase: Subjects receive implantation of epidural spinal cord test electrodes, and undergo rehabilitation training with closed-loop epidural electrical stimulation based on signals from the implanted electrodes. Follow-up Phase: It mainly involves functional training with closed-loop epidural electrical stimulation based on scalp EEG signals, as well as follow-up observation. |
| Measure | Description | Time Frame |
|---|---|---|
| Grasping Success Rate | The proportion of successful attempts in completing designated grasping movements, including basic grasping and functional grasping | Before surgery and 1 week, 1 month, and 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Grasping Object Type Coverage | The types of objects that can be accurately grasped (e.g., water cups, mobile phones, paper) | Before surgery and 1 week, 1 month, and 3 months after surgery |
| Brain-Controlled Command Recognition Accuracy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Chen, PhD | Contact | +862164041990 | chen.jing7@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jing Ding, PhD | Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Zhongshan Hospital | Shanghai | Shanghai Municipality | 200032 | China |
IPD (Individual Participant Data) contains individual information of participants (such as demographic characteristics, medical history, examination results, and intervention responses). Even after the "de-identification process", there remains a risk that the participants' identities could be inferred through cross-validation (e.g., by combining regional, age, and disease characteristics).
Compliance with global privacy protection regulations-such as China's Personal Information Protection Law-is required, as these regulations clearly stipulate that "individual sensitive medical data shall not be disclosed unless necessary" to prevent infringement of rights and interests (such as discrimination and identity abuse) caused by privacy leaks.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 20, 2025 | Dec 29, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2025 | Dec 29, 2025 | ICF_001.pdf |
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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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The correctness of converting electroencephalographic (EEG) signals into grasping commands
| Before surgery and 1 week, 1 month, and 3 months after surgery |
| Grasping Latency | The time interval from when the brain generates a grasping intention to the execution of the grasping action | Before surgery and 1 week, 1 month, and 3 months after surgery |
| Manual Muscle Testing (MMT) | Change from baseline in muscle strength assessed using the Medical Research Council (MRC) Manual Muscle Testing scale (grade 0-5; higher grade indicates greater muscle strength/better outcome). | Before surgery and 1 week, 1 month, and 3 months after surgery |
| Modified Ashworth Scale (MAS) for Spasticity | Change from baseline in spasticity assessed using the Modified Ashworth Scale (MAS; 0-4 with a 1+ category; higher score indicates more severe spasticity/worse outcome). | Before surgery and 1 week, 1 month, and 3 months after surgery |
| 3-Meter Walking Time | Change from baseline in time to complete a 3-meter walk, measured in seconds (s); lower time indicates better walking performance/better outcome. | Before surgery and 1 week, 1 month, and 3 months after surgery |
| Step Width (Motion Capture) | Change from baseline in step width measured by motion capture gait analysis, reported in centimeters (cm). | Before surgery and 1 week, 1 month, and 3 months after surgery |
| Step Length (Motion Capture) | Change from baseline in step length measured by motion capture gait analysis, reported in centimeters (cm); greater step length generally indicates better gait performance. | Before surgery and 1 week, 1 month, and 3 months after surgery |
| Step Height (Motion Capture) | Change from baseline in step height measured by motion capture gait analysis, reported in centimeters (cm). | Before surgery and 1 week, 1 month, and 3 months after surgery |
| Step Frequency (Motion Capture) | Change from baseline in step frequency measured by motion capture gait analysis, reported in steps per minute (steps/min); higher frequency generally indicates better gait performance. | Before surgery and 1 week, 1 month, and 3 months after surgery |
| Walking Speed (Motion Capture) | Change from baseline in walking speed measured by motion capture gait analysis, reported in centimeters per second (cm/s); higher speed indicates better gait performance/better outcome. | Before surgery and 1 week, 1 month, and 3 months after surgery |
| Plantar Pressure Value | Change from baseline in plantar peak pressure assessed using a plantar pressure measurement system, reported in kilopascals (kPa). | Before surgery and 1 week, 1 month, and 3 months after surgery |
| Limb Muscle Volume | Change from baseline in limb muscle volume assessed using imaging-based volumetry, reported in cubic centimeters (cm³); higher volume indicates greater muscle mass/better outcome. | Before surgery and 1 week, 1 month, and 3 months after surgery |
| Visual Analog Scale (VAS) | Change from baseline in pain intensity assessed using the Visual Analog Scale (VAS; 0-10, where 0 = no pain and 10 = worst pain imaginable); higher score indicates worse pain/worse outcome. | Before surgery and 1 week, 1 month, and 3 months after surgery |
| Sexual Health Inventory for Men (SHIM) / Sexual Complaints Screener for Women (SCS-W) | Change from baseline in male sexual function assessed using the Sexual Health Inventory for Men (SHIM; total score 1-25); higher score indicates better erectile function/better outcome. OR Change from baseline in female sexual complaints assessed using the Sexual Complaints Screener for Women (SCS-W; total score 0-60); higher score indicates greater symptom severity/worse outcome. | Before surgery and 1 week, 1 month, and 3 months after surgery |
| International Consultation on Incontinence Questionnaire-Short Form (ICI-Q-SF) Score for Urinary Retention | Change from baseline in urinary symptoms assessed using the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF; total score 0-21); higher score indicates more severe urinary symptoms/worse outcome. | Before surgery and 1 week, 1 month, and 3 months after surgery |
| Neurogenic Bowel Dysfunction (NBD) | Change from baseline in bowel function assessed using the Neurogenic Bowel Dysfunction (NBD) score (total score 0-47); higher score indicates more severe bowel dysfunction/worse outcome. | Before surgery and 1 week, 1 month, and 3 months after surgery |
| D014947 | Wounds and Injuries |