Implant for Walking After Incomplete SCI (NCT06965127) | Clinical Trial Compass
RecruitingNot Applicable
Implant for Walking After Incomplete SCI
United States5 participantsStarted 2025-08-27
Plain-language 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 - 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
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Difference in maximum walking distance
Timeframe: Immediately after the participant is fully trained to use their implanted system