Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery

Not Applicable

Recruiting

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

• Registration Number: NCT06701422
• Lead Sponsor: Columbia University

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).

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 Timeline

• Study First Submitted: 2024-11-13
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-22
• Study Start: 2024-12-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-15
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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)

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

The Daniel and Jane Och Spine Hospital at NewYork-Presbyterian/Allen; 🇺🇸 New York, New York, United States