Implant for Walking After Incomplete SCI

Launched by CLEVELAND VA MEDICAL RESEARCH AND EDUCATION FOUNDATION · May 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special device that is implanted into the body to see if it can help improve walking for people who have had an incomplete spinal cord injury (SCI). The trial has two main parts: first, it checks if a person qualifies to receive the device, and then it involves actually implanting the device and developing ways for the person to use it effectively over a couple of years. The goal is to understand how well this device can support walking in individuals with certain types of muscle weakness due to their injuries.

To be eligible for this trial, participants need to be between 18 and 75 years old and have paralysis from their SCI that affects their trunk and/or legs, with some preserved sensation or movement. They should also be unable to walk faster than a specific speed during a walking test and have been injured for at least six months. Participants will be closely monitored and supported throughout the process, and they need to be willing to attend follow-up appointments. It’s important to note that certain health conditions or physical limitations may prevent someone from participating, so a thorough evaluation will be done to ensure safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Between the ages of 18-75
• • Non-ventilator dependent paralysis resulting from injuries such as: cervical/thoracic spinal cord injuries affecting the trunk and/or lower limbs
• • Impairment classification of AIS B, C, or D (preservation of sensation and/or some motor function) with weakness in trunk and/or lower extremity muscles
• • Unable to walk faster than 0.8m/s during a 10m walk test
• • Gait deviation such as reduced peak hip, knee, and/or ankle range of motion during stance or swing phases due to motor impairment
• • Time post injury greater than six months
• • Innervated and excitable lower extremity and trunk musculature
• • Adequate social support and stability
• • Willingness to comply with follow-up procedures
• • Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
• • Neurologically stable as determined by a physician
• Exclusion Criteria:
• • Significant fracture risk or history of spontaneous fractures
• • History of heterotopic ossification at the hip, knee, or ankle
• • Non-English speaking
• • Insufficient upper extremity function to use an assistive device (e.g. walker or cane)
• • Females who are pregnant
• • Current pressure injury that would be exacerbated by study activities
• • Uncontrolled spasticity that would interfere with study activities
• • Significant range of motion limitations that would compromise study activities
• • History of vestibular dysfunction, balance problems, or spontaneous falls
• • Disorder or condition that require MRI monitoring
• • Acute and/or untreated orthopedic issues that would prevent weight bearing or exercising implanted muscles such as a dislocation or fracture
• • Acute and/or chronic medical problems left untreated or not controlled that would increase risk by using stimulation such as cardiac abnormalities, immunological/pulmonary/renal/circulatory compromise
• • Uncontrolled diabetes or hypertension
• • Presence of a demand pacemaker, cardiac defibrillator, or neuroprosthesis system with components in the legs
• • Any other medical or psychological condition that would be a contraindication
• • Implant eligibility criteria
• • • In addition to all of the above, the participant must be able to fully support their body weight in standing with an assistive device prior to implantation.