NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators

CompletedOBSERVATIONAL
Enrollment

34

Participants

Timeline

Start Date

November 1, 2014

Primary Completion Date

January 31, 2017

Study Completion Date

January 31, 2017

Conditions
Chronic PainSciaticaFailed Back Surgery Syndrome
Interventions
PROCEDURE

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.

PROCEDURE

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)."

Trial Locations (4)

17033

Penn State Hershey Neurosciences Institute, Hershey

17822

Geisinger Medical Center, Danville

18015

St. Luke's University Health Network, Bethlehem

19107

Thomas Jefferson University, Philadelphia

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Abbott Medical Devices

INDUSTRY

lead

St. Luke's Hospital, Pennsylvania

OTHER