Early Feasibility Study of Transcutaneous Electrical Stimulation to Improve Arm, Hand, Leg, and Foot Movements in Adults with Paralysis or Paresis from Spinal Cord Injury, Stroke, or BrainNerve Injuries

What this Trial Is About

Researchers are evaluating whether transcutaneous neuromuscular electrical stimulation, with or without transcutaneous spinal cord stimulation, using an investigational neurostimulation device can improve arm and hand movements in people with paralysis or weakness caused by spinal cord injury, stroke, or other brain or nerve injuries. This early feasibility trial aims to study functional improvements in both upper and lower limbs depending on the type of injury. Participants will attend up to 5 study sessions per week for up to one year, with each session lasting as long as 4 hours. During sessions, the study team will manually map and then deliver electrical stimulation to muscles andor the spinal column to evoke specific limb movements. Electroconductive gels or hydrogels will be used to assist electrode placement. The study includes four groups healthy volunteers and individuals with spinal cord injury, stroke, or other brain or nerve injuries, all receiving stimulation targeted to improve movement. At the first session, demographic information and vital signs will be collected, along with baseline clinical evaluations of movement and sensation. Throughout the study, participants will perform tasks designed to improve movement, with assessments using visual inspection, electromyography, motion tracking, and various validated clinical tests to measure functional changes. Participation ends after the last session when functional improvements are evaluated against baseline. The primary outcome is device feasibility for changing muscle activation over 12 months.

Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis