Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery

Columbia University

Status: Enrolling

Conditions: Cervical Myelopathy; Tetraplegia/Tetraparesis; Cervical Spinal Cord Injury

Treatments: Procedure: Intraoperative stimulation of the cervical spinal cord

Study type: Interventional

Funder types: Other

Identifiers

NCT06701422

AAAV1303

Details and patient eligibility

About

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).

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Arm 1 - Intraoperative Participants

Experimental group

Description:

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.

Treatment:

Procedure: Intraoperative stimulation of the cervical spinal cord