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Investigating Epidural Spinal Stimulation for Upper Limb Function After Spinal Cord Injury

This study is looking at how a device called the CoverEdgeX 32 Surgical Lead, which delivers epidural spinal stimulation (ESS), might help people with cervical spinal cord injuries (neck injuries) regain movement and feeling in their arms and hands. While this device is FDA-approved for pain, in this study it's considered investigational for spinal cord injury. Researchers will combine ESS with upper body training. They want to see if this combination can improve upper limb muscle responses. You might be able to join if you are 22-65 years old, have a stable medical condition, and are willing to follow all study procedures. The study plans to enroll 12 participants.

Study design
This is an interventional study with a planned enrollment of 12 participants. It is not specified if the study is randomized or blinded.
What's involved
You would undergo a clinical examination and screening, have ESS electrodes implanted, and then participate in combined therapies with ESS for several weeks. Assessments will be done at baseline, after intervention, and at follow-up weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed up at Week 10 and Week 13 after the intervention.

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NCT06225245

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

Recruiting
NAAges 22–65InterventionalTreatment
The Methodist Hospital Research Institute
~12 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:Epidural Spinal Stimulation (ESS)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of Upper Limb Muscle Response
Measured over Baseline (Week 4), Post Intervention (Week 7), Follow up (Week 10), Follow up (Week 13)

Conditions

Spinal Cord Injuries
Cervical Spinal Cord Injury

Explore related trials

Cervical spinal cord injury

NCT06225245

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • The Methodist Hospital Research Institute

    Houston, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Dimitry Sayenko, MD, PhD · PRINCIPAL_INVESTIGATOR · The Methodist Hospital Research Institute

Who to contact

Jenny Dinh
[email protected]
346-238-4654
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Assessment of Upper Limb Muscle ResponseBaseline (Week 4), Post Intervention (Week 7), Follow up (Week 10), Follow up (Week 13)

    Neuromotor outcomes in the upper limb muscles will be assessed, specifically targeting the upper arm, forearm, wrist, and fine motor movements. Measurements will be conducted during voluntary effort without spinal stimulation, as well as in the presence of Epidural Spinal Stimulation (ESS). The force output will be quantified in newtons (N), while the magnitude of EMG signals will be measured and expressed in millivolts (mV).