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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Grasping Success Rate
The proportion of successful attempts in completing designated grasping movements, including basic grasping and functional grasping
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Grasping Object Type Coverage
The types of objects that can be accurately grasped (e.g., water cups, mobile phones, paper)
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
Brain-Controlled Command Recognition Accuracy
The correctness of converting electroencephalographic (EEG) signals into grasping commands
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Before surgery and 1 week, 1 month, and 3 months after surgery
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