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Clinical Trials/NCT06701422
NCT06701422
Recruiting
Not Applicable

Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery

Columbia University2 sites in 1 country36 target enrollmentDecember 6, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Spinal Cord Injury
Sponsor
Columbia University
Enrollment
36
Locations
2
Primary Endpoint
Efficacy of epidural SCS
Status
Recruiting
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 6, 2024
End Date
June 30, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jason Carmel

Associate Professor

Columbia University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Efficacy of epidural SCS

Time Frame: 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

Time Frame: 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.

Study Sites (2)

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