Understanding and Enhancing Human Health and Movement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLouis Stokes VA Medical Center
About this trial
By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic brain injury.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Skeletal maturity and ability to sign informed consent (>18 years)
Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs
Innervated and excitable lower extremity and trunk musculature
Adequate social support and stability
Disqualifiers
Non-English speaking
Females who are pregnant
Current pressure injuries that would be exacerbated by study activities
Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities
Trial design
Design model
Single group
Treatments tested in this trial
Neural Prosthesis
Deviceimplanted electrical stimulation device
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Neural StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Difference in Max Standing Time
Time frame
Study completion - an average of 1 year2
Difference in Max Walking distance
Time frame
Study completion - an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov