Status:
RECRUITING
Implant for Walking After Incomplete SCI
Lead Sponsor:
Louis Stokes VA Medical Center
Collaborating Sponsors:
MetroHealth Medical Center
CDMRP
Conditions:
Spinal Cord Injury (SCI)
Gait
Eligibility:
All Genders
18-75 years
Phase:
NA
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 - thi...
Detailed Description
The purpose of this study is to evaluate the effects of neural stimulation for improving walking after incomplete spinal cord injury. Participants will conduct pre-surgical gait training and then unde...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2031
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06965127
Start Date
August 27 2025
End Date
August 1 2031
Last Update
November 26 2025
Active Locations (1)
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1
Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio, United States, 44106