Short-Term Transcutaneous or Epidural Spinal Stimulation for Enabling Motor Function in Humans With SCI
Paraplegia, Tetraplegia, Paralysis
About this trial
This is an interventional basic science trial for Paraplegia
Eligibility Criteria
Inclusion Criteria:
- Spinal cord injury due to trauma located at or above the tenth thoracic vertebrae (T10)
- American Spinal Injury Association grading scale of A-D (2 from each) below the level of SCI
- Intact spinal reflexes below the level of SCI
- At least 1-year post-SCI
- At least 22 years of age
- Willing to use medically acceptable methods of contraception, if female and of child-bearing potential
Exclusion Criteria:
- Currently a prison inmate, or awaiting trial, related to criminal activity
- Pregnancy at the time of enrollment
- History of chronic and/or treatment resistant urinary tract infection
- Unhealed decubitus ulcer
- Unhealed skeletal fracture
- Untreated clinical diagnosis of depression
- Undergoing, or planning to undergo, diathermy treatment
- Active participation in another interventional clinical trial
- Presence of conditions or disorders which require MRI monitoring
- A history of coagulopathy or other significant cardiac or medical risk factors for surgery
- Current use of a ventilator
- Clinically diagnosed cardiopulmonary complications such as chronic obstructive pulmonary disease, cardiac failure, or heart arrhythmia that contraindicate changes in body position such as supine-to-sit-to-stand activities, prolonged standing, or stepping
- History of frequent hypotension characterized by light headedness, or loss of consciousness
- History of frequent hypertension characterized by headache, or bradycardia
- History of frequent, severe, autonomic dysreflexia
- 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.
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Percutaneous Epidural Stimulation
Transcutaneous Epidural Stimulation
Epidural spinal stimulation will be delivered via percutaneously implanted electrodes during rehabilitation. All implanted electrodes will be removed at the end of trial participation. The effects of epidural stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.
Transcutaneous spinal stimulation will be delivered via skin surface-level electrodes during rehabilitation. The effects of transcutaneous stimulation will be recorded via electrophysiological and biomechanical metrics described within the outcomes measures.