Tetraplegic Motor Dysfunction Following Brainstem or Spinal Cord Injury
Conditions
Brief summary
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.
Interventions
OTHERInvasive BCI
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.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18-65 years old (no gender restriction) * Clinically diagnosed with tetraplegic motor dysfunction following brainstem or spinal cord injury * ≥ 6 months after brainstem or spinal cord injury, with stable condition (spinal shock phase has passed, and no significant improvement or deterioration in sensory and motor function) * Bilateral upper limb muscle strength ≤ Grade 2 and bilateral lower limb muscle strength ≤ Grade 3 by Manual Muscle Testing (MMT) * Cognitive function: Mini-Mental State Examination (MMSE) score ≥ 20
Exclusion criteria
* Females who are pregnant * History of drug abuse or alcoholism * Diseases that limit limb mobility: fractures (progressive/deformity-causing fractures), hip dysplasia and other diseases causing limited hip mobility, diabetic foot, severe osteoporosis, limb joint contracture deformity, spasticity, and hospitalization due to autonomic dysreflexia in the past 3 months * Neurological diseases/injuries: traumatic brain injury, epilepsy, neurodegenerative diseases or neuropathies, severe anxiety or depression, and suicidal ideation * Surgical contraindications: infectious diseases; unstable angina pectoris, severe arrhythmia, and other heart diseases; immune system diseases and major organ diseases; coagulation disorders and bleeding tendencies; ankylosing spondylitis; malignant tumors; spinal instability and spinal stenosis * BMI ≥ 30.0 kg/m² * Patients with depressive disorder (17-item Hamilton Depression Rating Scale \[HAMD\] score \> 17) * Patients unable to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grasping Success Rate | Before surgery and 1 week, 1 month, and 3 months after surgery | The proportion of successful attempts in completing designated grasping movements, including basic grasping and functional grasping |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grasping Object Type Coverage | Before surgery and 1 week, 1 month, and 3 months after surgery | The types of objects that can be accurately grasped (e.g., water cups, mobile phones, paper) |
| Brain-Controlled Command Recognition Accuracy | Before surgery and 1 week, 1 month, and 3 months after surgery | The correctness of converting electroencephalographic (EEG) signals into grasping commands |
| Grasping Latency | Before surgery and 1 week, 1 month, and 3 months after surgery | The time interval from when the brain generates a grasping intention to the execution of the grasping action |
| Manual Muscle Testing (MMT) | Before surgery and 1 week, 1 month, and 3 months after surgery | 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). |
| Modified Ashworth Scale (MAS) for Spasticity | Before surgery and 1 week, 1 month, and 3 months after surgery | 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). |
| 3-Meter Walking Time | Before surgery and 1 week, 1 month, and 3 months after surgery | Change from baseline in time to complete a 3-meter walk, measured in seconds (s); lower time indicates better walking performance/better outcome. |
| Step Width (Motion Capture) | Before surgery and 1 week, 1 month, and 3 months after surgery | Change from baseline in step width measured by motion capture gait analysis, reported in centimeters (cm). |
| Step Length (Motion Capture) | Before surgery and 1 week, 1 month, and 3 months after surgery | Change from baseline in step length measured by motion capture gait analysis, reported in centimeters (cm); greater step length generally indicates better gait performance. |
| Step Height (Motion Capture) | Before surgery and 1 week, 1 month, and 3 months after surgery | Change from baseline in step height measured by motion capture gait analysis, reported in centimeters (cm). |
| Step Frequency (Motion Capture) | Before surgery and 1 week, 1 month, and 3 months after surgery | 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. |
| Walking Speed (Motion Capture) | Before surgery and 1 week, 1 month, and 3 months after surgery | 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. |
| Plantar Pressure Value | Before surgery and 1 week, 1 month, and 3 months after surgery | Change from baseline in plantar peak pressure assessed using a plantar pressure measurement system, reported in kilopascals (kPa). |
| Limb Muscle Volume | Before surgery and 1 week, 1 month, and 3 months after surgery | 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. |
| Visual Analog Scale (VAS) | Before surgery and 1 week, 1 month, and 3 months after surgery | 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. |
| Sexual Health Inventory for Men (SHIM) / Sexual Complaints Screener for Women (SCS-W) | Before surgery and 1 week, 1 month, and 3 months after surgery | 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. |
| International Consultation on Incontinence Questionnaire-Short Form (ICI-Q-SF) Score for Urinary Retention | Before surgery and 1 week, 1 month, and 3 months after surgery | 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. |
| Neurogenic Bowel Dysfunction (NBD) | Before surgery and 1 week, 1 month, and 3 months after surgery | 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. |
Countries
China
Contacts
CONTACTJing Chen, PhD
STUDY_CHAIRJing Ding, PhD
Fudan University
Outcome results
None listed