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

Recruiting now · Not applicable

Conditions studied: Spinal Cord Injuries, Cervical Spinal Cord Injury

In brief

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 facts

Study ID

NCT06225245

Run by

The Methodist Hospital Research Institute

People needed

12

Starts

2024-08-06

Expected to finish

2027-01-01

Last updated by the study team

2026-04-08

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: accepted.

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;
• ability to passively flex and extend fingers.
• Maintain current oral anti-spasticity regimen/dosage as approved by study physician with no change in regular use that may affect study outcomes.
• Six (6) months to 20 years post spinal cord injury.
• Non-progressive spinal cord injury.
• Chronic SCI with neurologic level of injury as defined by ISNCSCI AIS A, B, or C.
• Neurological level of injury above T2.
• Eligible for fMRI per safety questionnaire.
• Women of childbearing potential must agree to the use of an effective means of avoiding pregnancy for the duration of the study.

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).
• Clinically significant depression, psychiatric disorders, or ongoing drug abuse.
• Any reason the PI or treating physician may deem as harmful to the participant or inappropriate for the participant to enroll or continue in the study.
• Body Mass Index (BMI) over 30.
• Pregnancy.

Where it is running

• The Methodist Hospital Research Institute — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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