Safety and Efficacy of High-Channel Implanted BCI for Motor Function Improvement in Tetraplegia P… (NCT07457645) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Efficacy of High-Channel Implanted BCI for Motor Function Improvement in Tetraplegia Patients
China10 participantsStarted 2026-05-15
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Grasping Success Rate
Timeframe: Before surgery and 1 week, 1 month, and 3 months after surgery