Safety and Efficacy of High-Channel Implanted BCI for Motor Function Improvement in Tetraplegia Patients

Официальное название

Safety and Efficacy of High-Channel Implanted Brain-Computer Interface in Promoting Motor Function Improvement in Patients With Tetraplegia

Обзор

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.

Вмешательства

• Другое Invasive 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 electric

Первичные конечные точки

• Grasping Success Rate [Срок оценки: Before surgery and 1 week, 1 month, and 3 months after surgery]

Вторичные конечные точки (12)

• Grasping Object Type Coverage [Срок оценки: Before surgery and 1 week, 1 month, and 3 months after surgery]
• Brain-Controlled Command Recognition Accuracy [Срок оценки: Before surgery and 1 week, 1 month, and 3 months after surgery]
• Grasping Latency [Срок оценки: Before surgery and 1 week, 1 month, and 3 months after surgery]
• Manual Muscle Testing (MMT) [Срок оценки: Before surgery and 1 week, 1 month, and 3 months after surgery]
• Modified Ashworth Scale (MAS) for Spasticity [Срок оценки: Before surgery and 1 week, 1 month, and 3 months after surgery]
• 3-Meter Walking Time [Срок оценки: Before surgery and 1 week, 1 month, and 3 months after surgery]
• Step Width (Motion Capture) [Срок оценки: Before surgery and 1 week, 1 month, and 3 months after surgery]
• Step Length (Motion Capture) [Срок оценки: Before surgery and 1 week, 1 month, and 3 months after surgery]
• Step Height (Motion Capture) [Срок оценки: Before surgery and 1 week, 1 month, and 3 months after surgery]
• Step Frequency (Motion Capture) [Срок оценки: Before surgery and 1 week, 1 month, and 3 months after surgery]
• Walking Speed (Motion Capture) [Срок оценки: Before surgery and 1 week, 1 month, and 3 months after surgery]
• Plantar Pressure Value [Срок оценки: Before surgery and 1 week, 1 month, and 3 months after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Zhongshan Hospital — Шанхай

Идентификаторы

NCT: NCT07457645 · B2025-473

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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