Augmenting Rehabilitation Outcomes and Functional Neuroplasticity Using Epidural Stimulation of Cervical Spinal Cord
Eligible age
22–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
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
Sponsor: The Methodist Hospital Research Institute
You may qualify if…
- ✓ 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 extension of approximately 150 degrees;
- ✓ neutral wrist position reaching a minimum of 70 degrees of movement (between flexion and extension;
You may not qualify if…
- ✕ 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).
- ✕ Any ongoing medical condition which would preclude participant from regular physical activity (including but not limited to: ventilator dependence, cardiopulmonary disease, uncontrollable autonomic dysreflexia or orthostatic hypotension, active urinary tract infections, pregnant or nursing).
- ✕ Intrathecal baclofen pump therapy for spasticity.
- ✕ Must not have received Botox injections to primary lower extremity and trunk musculature within the past 3 months which would result in absence of muscle tone and thus preclude response to electrical stimulation therapy.
- ✕ Current or history of neuromuscular conditions (including but not limited to: unhealed ligament of muscular tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities).
Where it's recruiting
Houston
Source: ClinicalTrials.gov · NCT06225245 · last updated 2026-04-08