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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Confirmed stable medical condition for participation by study physician.
* 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 as defined by study protocol
* 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 spinal cord injury classified as ASIA Impairment Scale (AIS) grade 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, or active urinary tract infections).
* Intrathecal baclofen pump therapy for spasticity.
* Botox injections to primary upper 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 muscle tears in the upper or lower extremities, pain in weight bearing positions for upper and lower extremities).
* Current or history of seizures or cerebral lesions.
* Clinically significant depression, psychiatric disorders, or ongoing drug abuse.
* Currently taking tricyclic anti-depressants, selective serotonin reuptake inhibitors (SSRIs), serotonin nor-epinephrine reuptake inhibitors (SNRI), or bupropion (Wellbutrin).
* 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 or nursing.

Where it's running

• 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: Dimitry Sayenko
• Email: sayenkolab@houstonmethodist.org
• Phone: 585-507-1706

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.