Actively Recruiting
Implant for Walking After Incomplete SCI
Led by Louis Stokes VA Medical Center · Updated on 2025-11-26
5
Participants Needed
1
Research Sites
309 weeks
Total Duration
On this page
Sponsors
L
Louis Stokes VA Medical Center
Lead Sponsor
M
MetroHealth Medical Center
Collaborating Sponsor
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Implant for Walking After Incomplete SCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between the ages of 18-75
- Non-ventilator dependent paralysis from cervical or thoracic spinal cord injuries affecting trunk and/or lower limbs
- Impairment classified as AIS B, C, or D with weakness in trunk and/or lower limb muscles
- Unable to walk faster than 0.8 meters per second during a 10-meter walk test
- Gait deviations due to motor impairment including reduced hip, knee, or ankle movement during walking
- Time since injury greater than six months
- Innervated and excitable trunk and lower extremity muscles
- Adequate social support and stability
- Willingness to comply with follow-up procedures
- Appropriate body size as determined by the study physician
- Neurologically stable as determined by a physician
- Able to fully support body weight while standing with an assistive device prior to implantation
You will not qualify if you...
- Significant fracture risk or history of spontaneous fractures
- History of heterotopic ossification at hip, knee, or ankle
- Non-English speaking
- Insufficient upper extremity function to use assistive devices such as a walker or cane
- Females who are pregnant
- Current pressure injuries that could worsen with study activities
- Uncontrolled spasticity interfering with study activities
- Significant motion limitations that would compromise study activities
- History of vestibular dysfunction, balance problems, or spontaneous falls
- Conditions requiring MRI monitoring
- Untreated orthopedic issues preventing weight bearing or muscle exercise
- Untreated or uncontrolled acute or chronic medical problems increasing risk with stimulation
- Uncontrolled diabetes or hypertension
- Presence of demand pacemaker, cardiac defibrillator, or neuroprosthesis system with leg components
- Any other medical or psychological condition that is a contraindication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio, United States, 44106
Actively Recruiting
Research Team
L
Lisa Lombardo, MPT
CONTACT
M
Maura Malenchek, PTA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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