Cervical Myelopathy, Cervical Spinal Cord Injury, Tetraplegia/Tetraparesis
Conditions
Keywords
spinal cord injury, upper-limb muscle activation, cervical spinal cord, myelopathy
Brief summary
The proposed study seeks to understand how the cervical spinal cord should be stimulated after injury through short-term physiology experiments that will inform a preclinical efficacy trial. The purpose of this study is to determine which cervical levels epidural electrical stimulation (EES) should target to recruit arm and hand muscles effectively and selectively in spinal cord injury (SCI).
Detailed description
For people with cervical spinal cord injury (SCI), regaining hand and arm function is their highest priority. Epidural stimulation enables recovery of walking and autonomic function in people with chronic SCI, but how the spinal cord should be stimulated to restore arm and hand function is not known. This project seeks to advance our understanding of how best to apply epidural electrical stimulation (EES) after cervical SCI using complementary experiments in humans and rats. This improved understanding will be used to conduct a preclinical study of the efficacy of different sites of cervical spinal cord stimulation.
Interventions
PROCEDUREIntraoperative stimulation of the cervical spinal cord
The surgeon will place spinal cord electrodes on the epidural surface, with stimulation sites identified using preoperative MRI. Recruitment curves will be generated by systematically increasing the stimulation intensity across various parameter combinations, including frequency, pulse count, pulse shape, and electrode-specific properties such as size, separation, and arrangement.
Sponsors
Congressionally Directed Medical Research Programs
Columbia University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
•Clinical indication for cervical spine surgery.
Exclusion criteria
•Stimulation devices in the neck or chest (e.g., vagal nerve stimulation, cardiac patients with pacemakers)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of epidural SCS | 0-100 milliseconds after each stimulation event during the experiment | Efficacy of stimulation is calculated as 1/threshold for provoking an motor evoked potentials. The threshold will be calculated from the recruitment curves. |
| Selectivity of epidural SCS | 0-100 milliseconds after each stimulation event during the experiment | Selectivity is calculated from the recruitment curves of the target muscle compared to non-targeted muscles. |
Countries
United States
Contacts
Primary ContactJason B Carmel, M.D., Ph.D.
Backup ContactJames R McIntosh, Ph.D.
Outcome results
None listed