Restoration of Standing and Walking With ISMS in Humans (NCT02899858) | Clinical Trial Compass
WithdrawnNot Applicable
Restoration of Standing and Walking With ISMS in Humans
Stopped: Funding stopped and no one met IRB approved enrollment criteria
United States0Started 2015-01
Plain-language summary
Spinal cord neural circuitry exists in the lumbar enlargement that makes it possible to stand and create synergistic, rhythmic stepping activity in the lower limbs. In the past 20 years, clinicians have tried to reengage such these circuits for standing and walking in the lower spinal cord of paralyzed humans through novel paradigms of physical therapy, pharmacological stimulation of the spinal cord, or recently - epidural stimulation of the spinal cord. Although standing and stepping with these maneuvers are rudimentary at best, these human studies offer promise to restore controlled, lower extremity movement to the spinal cord injured (SCI) individual. Evidence from animal data suggests that more focal activation of intraspinal circuitry (IntraSpinal Micro-Stimulation - ISMS) would produce more fatigue resistant, natural standing and stepping activity in humans. To date, there has been no direct confirmation of such circuitry in the spinal cord of bipedal humans who have been paralyzed. Furthermore, mapping of such circuitry would provide the basis of a novel intraspinal neuroprosthetic that should be able to restore control of standing or walking in a manner that is much more physiologically normal and tolerable than by stimulating each individual muscle group. Proof of the existence of these spinal circuits in man, and the ability to activate and control these circuits by first mapping the spinal cord is the basis of this proposal.
Who can participate
Age range18 Years – 50 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age 18-50 years old; male or female (no preference).
✓. Complete paraplegia (ASIA A classification) as a result of a spinal cord injury between the levels of T2-8.
✓. Patients with involuntary spasms are allowed. However, spasticity must be less than Ashworth 4 or spasm rating of 3 or less.
✓. History of spinal cord injury greater than 1 year.
✓. Intent to undergo spine surgery involving exposure of at least T9-T12 vertebral lamina.
✓. MRI studies performed within the past year showing presence of spinal cord between T8-L1 with reasonable normal anatomical shape. No chronic infections.
✓. Ability to travel to Vanderbilt Medical Center.
Exclusion criteria
✕. Acute medical conditions that are under active treatment. Examples include active urinary tract infection, respiratory illness, decubital ulcers, fractures, upper extremity injury, back pain.