Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery

NCT06701422 — Not applicable, Recruiting, 36 participants, Columbia University

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Registry	NCT06701422
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, basic science
Enrollment	36 (Estimated)
Sponsor	Columbia University (Other); collaborators: Congressionally Directed Medical Research Programs
Conditions	Cervical Spinal Cord Injury, Tetraplegia/Tetraparesis, Cervical Myelopathy
Interventions	Intraoperative stimulation of the cervical spinal cord (Procedure)
Dates	start 2024-12-06, primary completion 2026-06-30 (estimated), completion 2026-06-30 (estimated), first posted 2024-11-22, last updated 2025-11-24
Locations	2 sites in United States

-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).

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Arm 1 - Intraoperative Participants	Experimental	Procedure: Intraoperative stimulation of the cervical spinal cord	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.

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.

+Outcome measures

Primary outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to any

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)

+Locations (2)

Facility	City	Country	Status
Columbia University Irving Medical Center	New York, New York	United States	Recruiting
The Daniel and Jane Och Spine Hospital at NewYork-Presbyterian/Allen	New York, New York	United States	Recruiting

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