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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-65
SponsorThe Methodist Hospital Research Institute

About this trial

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

Eligibility criteria

Qualifiers

All participants must provide a signed and dated informed consent form.

Stated willingness to comply with all study procedures and availability for the duration of the study.

Male or female aged 22 - 65 years old.

Must provide documentation from personal primary treating physician that reports stable medical condition.

Disqualifiers

Currently involved in another rehabilitation training study.

Lower motor neuron injury revealed in the upper limbs.

Stabilization hardware in the cervical spine, preventing implantation of ESS system.

Active pressure sores, wounds, unhealed bone fractures, peripheral neuropathies, or painful musculoskeletal dysfunction (including contractures in the upper and lower extremities).

Trial design

Treatments tested in this trial

  • Epidural Spinal Stimulation (ESS)

Treatment groups

12 Participants
are divided into 1 treatment group