Brain-Controlled Spinal Cord Stimulation Using ECoG and Epidural Electrical Stimulation for Upper Limb Recovery in Adults with Cervical Spinal Cord Injury

What this Trial Is About

Researchers are investigating a new system that uses brain signals to control electrical stimulation of the spinal cord in people with cervical spinal cord injury. This approach aims to restore voluntary arm movements by connecting motor intentions from the brain to spinal cord stimulation below the injury. The study focuses on safety and early effectiveness in three participants with chronic, severe spinal cord injuries who have significant upper limb impairment. The investigational treatment involves implanting a neuroprosthetic device combining a 64-channel electrocorticography ECoG array over the motor cortex and a 32-channel cervical epidural electrical spinal cord stimulation system. This system decodes the participants motor intentions and translates them into muscle-specific electrical stimulation to promote arm movement. The implanted device allows continuous brain signal recording and spinal cord stimulation designed to restore voluntary control and support neurorehabilitation. Participants will undergo assessments of safety through monitoring serious adverse events during the 12-month study. Functional outcomes related to upper limb strength, sensation, motion range, and motor control will be measured using several standardized tests over 7 months. The study includes monitoring neurological status, muscle force, and sensory evoked potentials. Participants are expected to engage in follow-up visits and comply with study protocols to help evaluate the systems impact on arm function and overall neurological recovery.

Brain Controlled Spinal Cord Stimulation in Participants With Cervical Spinal Cord Injury for Upper Limb Rehabilitation