Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery

NCT ID: NCT06701422

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-06

Study Completion Date

2026-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Cervical Spinal Cord Injury Tetraplegia/Tetraparesis Cervical Myelopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Arm 1 - Intraoperative Participants

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.

Group Type EXPERIMENTAL

Intraoperative stimulation of the cervical spinal cord

Intervention Type 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.

Interventions

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Intraoperative 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Congressionally Directed Medical Research Programs

FED

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Jason Carmel

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Columbia University Irving Medical Center

New York, New York, United States

Site Status RECRUITING

The Daniel and Jane Och Spine Hospital at NewYork-Presbyterian/Allen

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jason B Carmel, M.D., Ph.D.

Role: CONTACT

917-301-1882

James R McIntosh, Ph.D.

Role: CONTACT

212-305-6616

Facility Contacts

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Jason B Carmel, M.D., Ph.D.

Role: primary

212-305-6616

Earl Thuet

Role: primary

212-932-4342

Other Identifiers

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CDMRP-SC230233

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AAAV1303

Identifier Type: -

Identifier Source: org_study_id

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