BCIwiki (bciwiki.com) — Xuanwu Hospital, Capital Medical University has registered a single-arm exploratory trial in the Chinese Clinical Trial Registry to evaluate a non-invasive brain-computer interface combined with spinal cord stimulation and exoskeleton rehabilitation for dysfunction after spinal cord injury. The registration number is ChiCTR2600125413 and the registration date is May 26, 2026.
The trial plans to enroll 10 participants aged 18 to 65, regardless of gender, with a first-enrolment date of May 30, 2026. At registration, recruitment had not yet begun. Inclusion criteria require a clinical diagnosis of spinal cord injury with confirmed motor dysfunction of the upper and/or lower limbs, at least 6 months since injury, and no significant improvement in motor function over the past 2 months despite at least 1 month of continuous conventional rehabilitation after injury. Patients must also meet the routine clinical implantation indications for spinal cord stimulation: refractory neuropathic pain lasting at least 3 months with a Visual Analogue Scale score of at least 5, and no response, poor efficacy or intolerance to side effects after standardized pharmacotherapy or conventional rehabilitation.
The study enrolls patients classified as Grade A, B or C on the American Spinal Injury Association Impairment Scale (AIS), and the registration states that during actual recruitment priority will be given to Grade B and C patients with partial preservation of descending neural pathways. The primary outcome is the overall clinical efficacy rate 6 months after surgery. Secondary outcomes include the improvement rate of the Visual Analogue Scale for pain, the incidence of adverse events related to the trial devices, and the overall clinical response rate at 6 months after surgery.
The intervention is a non-invasive brain-computer interface combined with spinal cord stimulation and exoskeleton rehabilitation therapy in a single experimental arm, with no control group. Funding comes from the Organized Research Special Project of the Capital Medical Science Innovation Center, under the project "Study on Electrical Stimulation and Motor Rehabilitation Therapy for Spinal Cord Injury Based on Brain-Spinal Cord-Muscle Functional Closed-Loop Regulation System," project number CX25YQ06. The registration page contains only bibliographic and design fields, with no results data; specific device models and actual enrollment numbers are not listed.