Implant for Walking After Incomplete SCI

A vizsgálat adatai

Ki végzi

Louis Stokes VA Medical Center

Azonosító

NCT06965127

A regiszteradat frissítve

2026. október 30.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

Enhancing Walking and Independence After Incomplete SCI With a Fully Implanted Neuroprosthesis

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.

Bevonási feltételek: 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.

Kizáró feltételek: 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.

ClinicalTrials.gov NCT06965127