Recruiting NCT06701422

Targeting Cervical Epidural Spinal Cord Stimulation for Functional Recovery

No phase Interventional Cervical Spinal Cord Injury Tetraplegia/Tetraparesis Cervical Myelopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Intraoperative stimulation of the cervical spinal cord.
Who it may be relevant to: Registry conditions: Cervical Spinal Cord Injury, Tetraplegia/Tetraparesis, Cervical Myelopathy. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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.

Primary outcome measures

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

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Basic science

Study locations

United States · 2 centers

Columbia University Irving Medical Center — New York
The Daniel and Jane Och Spine Hospital at NewYork-Presbyterian/Allen — New York

Identifiers

NCT: NCT06701422 · AAAV1303 · CDMRP-SC230233

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗