NCT06701422

Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cervical Spinal Cord Injury
• Tetraplegia/Tetraparesis
• Cervical Myelopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-06
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-11-22
• Last updated: 2025-11-24

Locations

2 sites across 1 country: United States