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

ConditionTetraplegic Motor Dysfunction Following Brainstem or Spinal Cord Injury

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorShanghai Zhongshan Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

Invasive BCI
Other intervention
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.

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: IBCIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Grasping Success Rate

The proportion of successful attempts in completing designated grasping movements, including basic grasping and functional grasping

Time frame