Recruiting

Cervical Epidural Stimulation

Sponsor:

Columbia University

Code:

NCT06701422

Conditions

Cervical Spinal Cord Injury

Tetraplegia/Tetraparesis

Cervical Myelopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intraoperative stimulation of the cervical spinal cord

Study Details

Brief 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).

Conditions

Cervical Spinal Cord Injury

Tetraplegia/Tetraparesis

Cervical Myelopathy

Study ID

NCT06701422

Start date

Dec 6, 2024

Status verified date

Nov, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Efficacy of epidural SCS [ Time Frame: 0-100 milliseconds after each stimulation event during the experiment ]
  • Selectivity of epidural SCS [ Time Frame: 0-100 milliseconds after each stimulation event during the experiment ]

Central Contacts and Locations

Central contacts

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

917-301-1882jbc28@cumc.columbia.edu

James R McIntosh, Ph.D.

212-305-6616jrm2263@cumc.columbia.edu

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

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

212-305-6616jbc28@cumc.columbia.edu

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

Recruiting

New York, New York, United States, 10034

Contacts

Earl Thuet

212-932-4342edt2116@cumc.columbia.edu

Principal Investigator:

Jason Carmel

More Information

Sponsor

Columbia University

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • spinal cord injury
  • upper-limb muscle activation
  • cervical spinal cord
  • myelopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-11-24.