💬In plain words
What the trial is, and whether it could suit you
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 wh
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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