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Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord

NCT06225245 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-04-08

No results posted yet for this study

Summary

The goal of this study is to investigate the effects of cervical epidural spinal stimulation with upper extremity training.

This is an investigational study. The device used for epidural spinal stimulation (ESS) to deliver spinal stimulation is called the CoverEdgeX 32 Surgical Lead system. This device is approved by the Food and Drug Administration (FDA) for the treatment of severe pain and to manage chronic pain when other treatments have not been effective. In this study, the device is considered an investigational device because it is not approved for use in the treatment of spinal cord injury

Conditions

  • Spinal Cord Injuries
  • Cervical Spinal Cord Injury

Interventions

DEVICE

Epidural Spinal Stimulation (ESS)

ESS will be delivered using The CoverEdgeX 32 Surgical Lead at frequencies of 0.2 to 60 Hz with intensity up to 10 mA, adjusted to induce motor threshold responses in the target muscle for the above motor task (e.g., biceps brachii for elbow flexion) \[31-33\]. The ESS controller will only be operated by trained study team members. Therefore, stimulation will only be delivered during study visits. Stimulation will be administered for a maximum duration of 1 hour total per visit, varying according to the individual's tolerance and fatigue levels, with 5 - 10 minutes breaks interspersed between intervals of stimulation.

Sponsors & Collaborators

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Dimitry Sayenko, MD, PhD · The Methodist Hospital Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-06
Primary Completion
2027-01-01
Completion
2027-01-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06225245 on ClinicalTrials.gov