NCT06965127 · Louis Stokes VA Medical Center
Implant for Walking After Incomplete SCI
What this study is about
This is a device study that will evaluate the effect of an implanted stimulator on improving walking in people with incomplete spinal cord injury.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 26, 2025 · Source of record for eligibility and locations