Study Summary
Electrode SCI is a prospective, longitudinal observational study aimed at validating high density intraoperative epidural recordings as a prognostic biomarker for motor recovery after acute human traumatic spinal cord injury (SCI).
Approximately 10 patients with acute traumatic cervical SCI are anticipated to enroll at Zuckerberg San Francisco General Hospital (ZSFG) within 24 hours of their injury.
In the intra-operative setting during the acute spine stabilization surgery after SCI, neuromonitoring in the form of cranial motor evoked potentials (cMEP) and somatosensory evoked potentials (cSSEP) is frequently utilized, but they provide incomplete information. Acute cMEPs may not correlate with long term clinical outcome. Post-operatively, patients generally recover in an intensive care unit with repeated neurological checks through the clinician’s physical exam, but without any local recording at the site of spinal cord injury. Thus, any detailed information recording local pathophysiology is lost and the physical exam serves as a crude surrogate.
Local epidural recording has the potential to add insight and serve as a biomarker for recovery. Electrophysiological measurements have long been noted to supplement other clinical information in providing prognosis after acute SCI. However, incomplete SCI patients can also recover some locomotor function without improvement in tibial SSEP, suggesting that intrinsic spinal cord neurophysiological changes are responsible. Neuromonitoring leads already exist for local recording during surgery, but are only available at low channel count (1-4 channels), and are rarely used for this purpose.
This study utilizes a novel, flexible, high density, 32 channel epidural electrode array capable of both recording and stimulation of the human central nervous system. The previously proven technology proposed on this program is a multilayer polymer-metalpolymer thin-film array. LLNL uses its isolated and quality-controlled equipment in a GMP (Good Manufacturing Practice) cleanroom facility to fabricate these parts. The array has already been used for human brain recordings in the context of epilepsy surgery. Here we propose the first in man use of a high-density flexible array for local epidural recordings after acute cervical SCI.
Study Site Locations
- University of California, San Francisco: Zuckerberg San Francisco General Hospital (San Francisco, California, United States of America)
What is involved?
- ​Access to the participant's hospitalization records for the SCI visit.
- Placement of an electrode array over the exposed cervical dura for <15 minutes during the participant's standard of care surgery.
- International Standard for Neurological Classification of Spinal Cord Injury (ISNCSCI) motor and sensory assessments conducted at 7 days and 6 months post-injury.
- Surface electromyography (EMG) recording, a non-medical procedure where electrodes are placed on the surface of the skin to measure the electrical activity produced by the muscles, at 7 days and 6 months post-injury.
- Questionnaires on demographics and medical history conducted on hospital admission.
Who can participate?
Patients who meet the following inclusion criteria are eligible for admission into the study, providing they do not meet exclusion criteria.
- ZSFG hospital admission less than 24 hours from time of injury
- Age 18-80, inclusive
- Ability to give written informed consent prior to their standard of care surgery
- Diagnosis of acute, traumatic spinal cord injury
AIS grade A - D - C3 - C8 neurological level of injury on ISNCSCI exam
- Imaging showing fracture and spinal canal compromise associated with the level of injury
- Surgical decompression scheduled within 24 hrs after injury
- Able to cooperate in the completion of standardized neurological examinations