Study of Brain-Controlled Spinal Cord Stimulation for Improving Arm and Leg Movement in Adults With Chronic Stroke

What this Trial Is About

This research aims to evaluate the preliminary safety and effectiveness of using a brain-controlled spinal cord stimulation device to restore voluntary movement in people with chronic stroke who have mobility impairments. The study focuses on establishing a direct connection between the participants motor intentions and spinal cord stimulation to improve or restore control of arm and leg movements and support neurological recovery when combined with rehabilitation. Participants will receive an implantable device called the ARC-BSI Stroke system, which includes a 64-channel electrocorticogram ECoG array placed over the motor cortex and two 16-channel spinal cord stimulation systems implanted over the cervical and lumbar regions. The brain signals decoded by the ECoG control the spinal cord stimulation in real time to assist with training and rehabilitation aimed at recovering voluntary movements. During the study, participants will undergo assessments before implantation and at multiple points after surgery, including 6 months, 1 year, and then yearly up to 5 years. Outcome measures include safety monitoring and evaluations of motor function, walking ability, muscle strength, spasticity, and neurological recovery using standardized tests and gait analyses. Participants are expected to attend all scheduled visits and comply with study procedures over the 5-year period.

Brain-controlled Spinal Cord Stimulation in Participants With Chronic Stroke for Lower and Upper Limb Rehabilitation