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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-SC230233 | Other Grant/Funding Number | U.S. Department of Defense, Congressionally Directed Medical Research Programs (CDMRP) |
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| Name | Class |
|---|---|
| Congressionally Directed Medical Research Programs | FED |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Intraoperative Participants | Experimental | Motor evoked responses responses (MEPs) to epidural electrical stimulation (EES) will be tested at cervical segments with and without myelopathy in participants with cervical myelopathy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative stimulation of the cervical spinal cord | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of epidural SCS | Efficacy of stimulation is calculated as 1/threshold for provoking an motor evoked potentials. The threshold will be calculated from the recruitment curves. | 0-100 milliseconds after each stimulation event during the experiment |
| Selectivity of epidural SCS | Selectivity is calculated from the recruitment curves of the target muscle compared to non-targeted muscles. | 0-100 milliseconds after each stimulation event during the experiment |
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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)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jason B Carmel, M.D., Ph.D. | Contact | 917-301-1882 | jbc28@cumc.columbia.edu | |
| James R McIntosh, Ph.D. | Contact | 212-305-6616 | jrm2263@cumc.columbia.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | Recruiting | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D011782 | Quadriplegia |
| D013119 | Spinal Cord Injuries |
| D013118 | Spinal Cord Diseases |
| ID | Term |
|---|---|
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| The Daniel and Jane Och Spine Hospital at NewYork-Presbyterian/Allen | Recruiting | New York | New York | 10034 | United States |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002493 | Central Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |