NCT06965127 Implant for Walking After Incomplete SCI

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 5 participants in total. It began in 2025-08-27 with a primary completion date of 2028-08.

Brief Summary

This is a device study that will evaluate the effect of an implanted stimulator on improving walking in people with incomplete spinal cord injury. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes implanting the device and setting the individual up for system use, creating controllers for walking, and evaluating the effect of the device over a couple years.

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.

Contact & Investigator

Frequently Asked Questions

Related Trials