The goal of this study is to investigate the effects of cervical epidural spinal stimulation with upper extremity training.
This is an investigational study. The device used for epidural spinal stimulation (ESS) to deliver spinal stimulation is called the CoverEdgeX 32 Surgical Lead system. This device is approved by the Food and Drug Administration (FDA) for the treatment of severe pain and to manage chronic pain when other treatments have not been effective. In this study, the device is considered an investigational device because it is not approved for use in the treatment of spinal cord injury
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.
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).
Single group
Epidural Spinal Stimulation (ESS)
DeviceESS will be delivered using The CoverEdgeX 32 Surgical Lead at frequencies of 0.2 to 60 Hz with intensity up to 10 mA, adjusted to induce motor threshold responses in the target muscle for the above motor task (e.g., biceps brachii for elbow flexion) \[31-33\]. The ESS controller will only be operated by trained study team members. Therefore, stimulation will only be delivered during study visits. Stimulation will be administered for a maximum duration of 1 hour total per visit, varying according to the individual's tolerance and fatigue levels, with 5 - 10 minutes breaks interspersed between intervals of stimulation.
Assessment of Upper Limb Muscle Response
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).
Assessment of Neurological Status
International Standards for Neurological Classification of SCI (ISNCSCI). The total motor score has a range of 0 to 100, with specific key muscles assessed on both sides of the body. The sensory scores also range from 0 to 112, evaluating light touch and pinprick sensation in different dermatomes.
Assessment of Independence
Spinal Cord Independence Measure (SCIM). The SCIM involves assessing various neurological functions and assigning scores. The SCIM has a scale ranging from 0 to 100, with higher scores indicating greater independence in activities of daily living. The minimum score signifies complete dependence, while the maximum score reflects complete independence.
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