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

Launched by THE METHODIST HOSPITAL RESEARCH INSTITUTE · Jan 17, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how a device called the CoverEdgeX 32 Surgical Lead system, which delivers electrical stimulation to the spinal cord, can help improve rehabilitation and recovery for people with cervical spinal cord injuries. The study aims to see if using this device alongside upper body exercises can enhance movement and function in the arms and hands. While the device is already approved for treating severe pain, its use for spinal cord injury is still being researched.

To participate in this trial, individuals need to be between 22 and 70 years old and must have had a stable spinal cord injury for at least six months but no more than 20 years. Participants should be able to move their arms and hands within certain ranges and must not have any serious medical conditions that could interfere with their ability to take part. Those who join can expect to engage in a structured rehabilitation program while being monitored for their progress. It’s important to note that this study is currently recruiting participants, and all details regarding participation will be thoroughly explained to ensure informed consent.

Gender

ALL

Eligibility criteria

• 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 - 70 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.
• Exclusion Criteria:
• • 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.