Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord
The Methodist Hospital Research Institute
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
Description
It has been demonstrated that electrical stimulation of the spinal cord can activate neural networks located below the site of spinal cord injury (SCI). Particularly, when combined with motor rehabilitation, the use of epidural spinal stimulation (ESS) at the lumbar spinal cord level has shown promise in promoting the recovery of lower limb motor function and enhancing overall well-being. In this project, the investigators propose a feasibility study to investigate the effectiveness of cervical ESS as a therapeutic approach for regaining upper limb (UL) sensorimotor function after SCI. Follow…
Eligibility
- Age range
- 22–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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. * Able to passively range bilateral upper extremities within normal mobility parameters including: * greater than 90 degrees of shoulder flexion and 20 degrees of shoulder extension; * greater than 120 degrees of elbow flexion and reach elbow ex…
Interventions
- DeviceEpidural 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.
Location
- The Methodist Hospital Research InstituteHouston, Texas