34
Participants
Start Date
November 1, 2014
Primary Completion Date
January 31, 2017
Study Completion Date
January 31, 2017
Awake
Upon approximate lead positioning, the patient is brought to a conscious sedated state while maintaining local anesthetic. Stimulation of the spinal cord through the paddle lead is accomplished with an external pulse generator, while communicating with the patient regarding paresthesia coverage of painful regions.
Non-Awake
"The patient is maintained under general anesthesia for the full duration of the implant. Upon approximate lead positioning, bilateral EMG of myotomes overlapping dermatomal regions of pain are monitored. Stimulation is delivered through the lead by an external pulse generator in order to elicit compound muscle action potentials (CMAPs) in the target regions. Lead placement is targeted to have symmetric CMAPs (i.e. physiologic midline) and adequate coverage of the painful regions as described by Falowski et al.~(Falowski et al., 2011)."
Penn State Hershey Neurosciences Institute, Hershey
Geisinger Medical Center, Danville
St. Luke's University Health Network, Bethlehem
Thomas Jefferson University, Philadelphia
Collaborators (1)
Abbott Medical Devices
INDUSTRY
St. Luke's Hospital, Pennsylvania
OTHER