NCT Number: NCT06701422
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Columbia University Irving Medical Center, New York, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
James R McIntosh, Ph.D.
CONTACT
Jason B Carmel, M.D., Ph.D.
CONTACT
Columbia University
Other
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