Using epidural stimulation to improve rehabilitation outcomes for cervical spinal cord injuries

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

This study is testing if a new treatment using epidural stimulation along with arm exercises can help people with cervical spinal cord injuries improve their arm function.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 22 Years to 65 Years
• Sex: All
• Sponsor: The Methodist Hospital Research Institute (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT06225245 on ClinicalTrials.gov

What this trial studies

This study investigates the effects of cervical epidural spinal stimulation (ESS) combined with upper extremity training on individuals with spinal cord injuries. Participants will undergo implantation of ESS electrodes, followed by a recovery phase and various assessments to evaluate sensorimotor function and brain activation. The study aims to determine the feasibility and effectiveness of this approach in enhancing upper limb function after spinal cord injury. The methodology includes electrophysiological assessments, neuroimaging, and functional evaluations over several weeks.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 22 to 70 years who are 6 months to 20 years post spinal cord injury and can demonstrate specific upper extremity mobility.

Not a fit: Patients with severe limitations in upper extremity mobility or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve upper limb function and quality of life for patients with cervical spinal cord injuries.

How similar studies have performed: Previous studies have shown promise with spinal cord stimulation techniques, but this specific approach using cervical ESS is novel and untested.

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 - 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 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.

Where this trial is running

Houston, Texas

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

Study contacts

• Principal investigator: Dimitry Sayenko, MD, PhD — The Methodist Hospital Research Institute
• Study coordinator: Jenny Dinh

Conditions Spinal Cord Injuries; Cervical Spinal Cord Injury