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RECRUITING
NCT06225245
NA

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

Sponsor: The Methodist Hospital Research Institute

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

22 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-08-06

Completion Date

2027-01-01

Last Updated

2026-04-08

Healthy Volunteers

Yes

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.

Locations (1)

The Methodist Hospital Research Institute

Houston, Texas, United States