Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)
Spinal Cord Injury at T1-T12 Level, Traumatic Thoracic Spinal Cord Contusion, Thoracic Spinal Cord Trauma
About this trial
This is an interventional treatment trial for Spinal Cord Injury at T1-T12 Level focused on measuring Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria:
Subjects enrolled in this study must meet all of the following inclusion criteria (based on investigator judgement):
- Traumatic, thoracic SCI
- Chronic pain (i.e., Pain >3 for > 3 months)
- Willing and able to provide informed consent, attend required study visits, and complete required assessments/questionnaires
- 18-80 years of age
- Medically stable enough to undergo surgical implantation of an SCS / participate in rehabilitation regimens
Exclusion Criteria:
Subjects enrolled in this study must not meet any of the following exclusion criteria (based on investigator judgement):
- Complete cord transection
- Persistent spinal instability or other injury preventing ability to participate
- Active infection
- Comorbid psychosis or psychotic disorder
- Untreated, clinically significant depression
- Active drug or alcohol abuse
- Pregnant women or women who intend to become pregnant during the duration of the study. Women of childbearing potential need a negative pregnancy test
Sites / Locations
- Duke University Health SystemsRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
EES on
EES off
Patients will undergo epidural electrical stimulation (EES) and be randomized in a 1:1 allocation to EES on. Both the patient and the provider will be formally blinded to treatment assignment. Only the biostatistician and programming team will be unblinded to treatment assignments.
Patients will undergo epidural electrical stimulation (EES) and be randomized in a 1:1 allocation to EES off. Both the patient and the provider will be formally blinded to treatment assignment. Only the biostatistician and programming team will be unblinded to treatment assignments.ES off. Those in the EES off category will have their EES turned on at the 9-month timepoint.