NCT06225245

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: The Methodist Hospital Research Institute · Academic / Other
• Sex: All
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed 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. Following the initial Week 1 Clinical examination and screening, Week 2 will involve implanting ESS electrodes with externalized leads into twelve participants (as per the Schema). After implantation in Week 3, participants will undergo a recovery phase. In Week 4, our objectives encompass: 1) characterizing sensorimotor network responses to ESS (electrophysiological assessment), 2) quantifying brain activation and functional connectivity during ESS (neuroimaging assessment), and 3) evaluating upper limb sensorimotor function with ESS (functional assessment). Weeks 5 and 6 introduce combined therapies for upper limb and trunk sensorimotor functions alongside cervical ESS. Week 7 mirrors Week 4 assessments, stratifying participants based on ESS responses into responders and non-responders; non-responders undergo ESS electrode removal, while responders receive permanent impulse pulse generator (IPG) implantation. The investigators anticipate that at least half, if not all, of the 12 participants will respond to ESS therapy and receive the IPG implant. Weeks 8 and 9 entail rest and repeated Clinical examinations. In Week 10, assessments occur with ESS active for only 30 seconds (Sham stimulation), continuing Weeks 11 and 12. Week 13 repeats assessments, followed by Weeks 14 and 15 refining ESS parameters for functional movements. The timeline culminates in a Week 16 post-intervention Clinical examination.

Conditions

• Spinal Cord Injuries
• Cervical Spinal Cord Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-06
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2024-01-25
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study