Implant for Walking After Incomplete SCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLouis Stokes VA Medical Center
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- NNP-LE
Treatment groups
5 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov