Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
* Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae
* American Spinal Injury Association grading scale of A, B, C, or D
* Intact spinal reflexes below the level of SCI
* SCI must have occurred at least 1 year prior to study enrollment
* At least 22 years of age
* If female, must be willing to use medically-acceptable method of contraception during study participation
Exclusion Criteria:
* Currently a prison inmate, or awaiting trial, related to criminal activity
* Pregnancy at the time of screening for trial enrollment
* Active, untreated urinary tract infection
* Unhealed decubitus ulcer
* Unhealed skeletal fracture
* Spinal abnormality that may impede percutaneous implantation of spinal electrodes
* Untreated clinical diagnosis of psychiatric disorder
* Joint contractures that impede typical range of motion
* Non-MRI-compatible implanted medical devices
* Other implanted stimulation devices (e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, etc.)
* Undergoing, or planning to undergo, diathermy treatment
* Active participation in an interventional clinical trial
* History of clinically-diagnosed cardiopulmonary disorder, such as severe orthostatic hypotension, which may impede participation in rehabilitation activities such as changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
* History of frequent and/or severe autonomic dysreflexia
* History of seizure disorder
* Any illness or condition which, based on the research team's assessment, will compromise with the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 12/06/2024. Questions regarding updates should be directed to the study team contact.