Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06701422
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intraoperative stimulation of the cervical spinal cord — PROCEDURE
    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.

Study Details

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).

Key Dates

Start date
Dec 6, 2024
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
36 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

Efficacy of epidural SCS [ Time Frame: 0-100 milliseconds after each stimulation event during the experiment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032
Jason B Carmel, M.D., Ph.D.
[email protected]
212-305-6616
James R McIntosh, Ph.D. (SUB_INVESTIGATOR)
The Daniel and Jane Och Spine Hospital at NewYork-Presbyterian/AllenNew YorkNew York10034
Earl Thuet
[email protected]
212-932-4342
Jason Carmel (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Irving Medical Center· New York, NYThe Daniel and Jane Och Spine Hospital at NewYork-Presbyterian/Allen· New York, NY

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