🔎 Trials Near Me

Home › Spinal Cord Injuries › NCT06965127

Implant for Walking After Incomplete SCI

Recruiting

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

Who can join

Ages 18 to 75 · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Louis Stokes VA Medical Center · Participants: 5 · Started: Aug 27, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06965127

Locations in the U.S.

OhioLouis Stokes Cleveland Veterans Affairs Medical Center, Cleveland

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.