NCT06243952 Brain Controlled Spinal Cord Stimulation In Participants With Spinal Cord Injury For Lower Limb Rehabilitation

Trial Parameters

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Brief Summary

The purpose of this clinical study is to evaluate the preliminary safety and effectiveness of using a cortical recording device (ECoG) combined with lumbar targeted epidural electrical stimulation (EES) of the spinal cord to restore voluntary motor functions of lower limbs in participants with chronic spinal cord injury suffering from mobility impairment. The goal is to establish a direct bridge between the motor intention of the participant and the the spinal cord below the lesion, which should not only improve or restore voluntary control of legs movement and support immediate locomotion, but also promote neurological recovery when combined with neurorehabilitation.

Eligibility Criteria

Inclusion Criteria: 1. Must provide Informed Consent as documented by signature (Appendix Informed Consent Form) prior to any study-related procedures, 2. Must be at least 18 years old and no older than 60 years old at the time of enrolment, 3. Must be suffering from non-progressive traumatic spinal cord injury, 4. Must be graded A, B, C, or D in the American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification, 5. Must have completed primary standard of care rehabilitation, 6. Must have stable medical, physical and psychological condition as considered by the investigator, 7. Must be lesioned at T10 or above, based on AIS level determination by the investigator, with preservation of conus function, 8. Must have sustained the injury at least 12 months before signing the consent form, 9. Must have residual upper limb function (capable of using a manual wheelchair), 10. Must be able to understand and interact with the study team in French or English, 11. Must agree to c

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