Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery
2 other identifiers
interventional
36
1 country
2
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2024
CompletedFirst Posted
Study publicly available on registry
November 22, 2024
CompletedStudy Start
First participant enrolled
December 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
November 24, 2025
November 1, 2025
1.6 years
November 13, 2024
November 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
Arm 1 - Intraoperative Participants
EXPERIMENTALMotor 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
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.
Eligibility Criteria
You may qualify if:
- Clinical indication for cervical spine surgery.
You may not qualify if:
- Stimulation devices in the neck or chest (e.g., vagal nerve stimulation, cardiac patients with pacemakers)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Columbia University Irving Medical Center
New York, New York, 10032, United States
The Daniel and Jane Och Spine Hospital at NewYork-Presbyterian/Allen
New York, New York, 10034, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 13, 2024
First Posted
November 22, 2024
Study Start
December 6, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
November 24, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share