Augmenting Upper Limb Function and Functional Neuroplasticity Using Epidural Stimulation of the Cervical Spinal Cord
Eligible age
22–70 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
This study will test whether spinal stimulation combined with rehabilitation can improve arm and hand function in people with tetraplegia after spinal cord injury. Tetraplegia causes weakness or paralysis in the arms and legs. The stimulation sends electrical pulses through a paddle placed near the spinal cord in the neck. Researchers will study changes in arm and hand function and how the brain and spinal cord respond. The study has two phases. \*\*Phase 1: Initial testing\*\* Participants will: * Complete screening to see whether they qualify. * Have surgery to place a stimulation paddle in the neck, with wires extending outside the body. * Take part in arm and hand exercises with spinal stimulation. * Complete tests to measure their response. The study team will check whether each participant meets the criteria to continue. Those who qualify may choose to enter Phase 2. Those who do not qualify will have the paddle and external wires removed and will not enter Phase 2. \*\*Phase 2: Permanent implant\*\* Participants will have surgery to implant a battery that powers the stimulation system. They will continue arm and hand exercises with stimulation. The study team will adjust the settings to support each participant's movement goals.
Sponsor: The Methodist Hospital Research Institute
You may qualify if…
- ✓ 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.
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, 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).
Where it's recruiting
Houston
Source: ClinicalTrials.gov · NCT06225245 · last updated 2026-10-26