Implant for Walking After Incomplete SCI

Who can take part

• 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

Who cannot take part

• 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
• Significant fracture risk or history of spontaneous fractures
• History of heterotopic ossification at the hip, knee, or ankle
• History of vestibular dysfunction, balance problems, or spontaneous falls
• Disorder or condition that require MRI monitoring
• 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
• 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
• Acute and/or untreated orthopedic issues that would prevent weight bearing or exercising implanted muscles such as a dislocation or fracture