Actively Recruiting
Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery
Led by Columbia University · Updated on 2025-11-24
36
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to improve how epidural electrical stimulation (EES) is applied to the cervical spinal cord to help people with cervical spinal cord injury (SCI) regain arm and hand function. The study focuses on understanding which cervical spinal levels should be targeted to effectively and selectively activate muscles in the arm and hand. It combines experiments in humans and rats to gather information that will guide future preclinical trials for improving functional recovery after SCI. Participants with cervical myelopathy undergoing cervical spine surgery will receive intraoperative stimulation of the cervical spinal cord. Surgeons will place electrodes on the epidural surface guided by preoperative MRI, then test motor evoked responses by adjusting stimulation intensity and parameters such as frequency, pulse count, pulse shape, and electrode positioning. This procedure aims to identify the best stimulation sites and settings to recruit arm and hand muscles. During the study, researchers will monitor the efficacy and selectivity of epidural spinal cord stimulation within 0 to 100 milliseconds after each stimulation event. The study involves short-term physiological experiments during surgery and tracks responses to stimulation at different cervical segments. The total participation time aligns with the surgical procedure and data collection. The study is sponsored by Columbia University and will run until June 2026.
CONDITIONS
Brief Title
Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical indication for cervical spine surgery
You will not qualify if you...
- Presence of stimulation devices in the neck or chest, such as vagal nerve stimulators or pacemakers
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - Surgery day plus immediate recovery period
Participants undergo cervical spine surgery during which spinal cord electrodes are placed on the epidural surface. Intraoperative stimulation is performed to test motor evoked responses to epidural electrical stimulation.
1 surgical procedure visit
Trial Site Locations
Total: 2 locations
1
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
2
The Daniel and Jane Och Spine Hospital at NewYork-Presbyterian/Allen
New York, New York, United States, 10034
Actively Recruiting
Research Team
J
Jason B Carmel, M.D., Ph.D.
J
James R McIntosh, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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