Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery

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).

Study Overview

• Status: Recruiting
• Conditions: Cervical Myelopathy; Cervical Spinal Cord Injury; Tetraplegia/Tetraparesis
• Intervention / Treatment: Procedure: Intraoperative stimulation of the cervical spinal cord

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason B Carmel, M.D., Ph.D.; Phone Number: 917-301-1882; Email: jbc28@cumc.columbia.edu
• Study Contact Backup: Name: James R McIntosh, Ph.D.; Phone Number: 212-305-6616; Email: jrm2263@cumc.columbia.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irving Medical Center
      • Sub-Investigator: James R McIntosh, Ph.D.
      • Contact: Jason B Carmel, M.D., Ph.D.; Phone Number: 212-305-6616; Email: jbc28@cumc.columbia.edu
    • New York, New York, United States, 10034
      • Recruiting
      • The Daniel and Jane Och Spine Hospital at NewYork-Presbyterian/Allen
      • Contact: Earl Thuet; Phone Number: 212-932-4342; Email: edt2116@cumc.columbia.edu
      • Principal Investigator: Jason Carmel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Congressionally Directed Medical Research Programs

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 19, 2024
• First Posted (Actual): November 22, 2024

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: spinal cord injury; upper-limb muscle activation; cervical spinal cord; myelopathy
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Spinal Cord Injuries; Quadriplegia; Spinal Cord Diseases
• Other Study ID Numbers: AAAV1303; CDMRP-SC230233 (Other Grant/Funding Number: U.S. Department of Defense, Congressionally Directed Medical Research Programs (CDMRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No