Status:
RECRUITING
Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)
Lead Sponsor:
Nandan Lad, M.D., Ph.D.
Conditions:
Spinal Cord Injury at T1-T12 Level
Traumatic Thoracic Spinal Cord Contusion
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The purpose of this feasibility study is to compare the impact of Spinal cord stimulation \[SCS\] for Spinal Cord Injury (SCI) pain and rehabilitation. SCS, also known as Epidural Electrical Stimulati...
Detailed Description
This study is a prospective, single center study. Data will be collected at baseline, time of procedure (trial and permanent), trial phase, and at 1, 3, 6, 12, 18, and 24 months post-implantation. Th...
Eligibility Criteria
Inclusion
- Subjects enrolled in this study must meet all of the following inclusion criteria (based on investigator judgement):
- Traumatic, thoracic SCI
- Chronic neuropathic 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
- 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
- Patients without symptoms of neuropathic pain \>3/10 for \> 3 months
- Patient deemed not medically stable for surgery
Key Trial Info
Start Date :
December 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04894734
Start Date
December 30 2021
End Date
October 31 2027
Last Update
December 17 2025
Active Locations (1)
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1
Duke University Health Systems
Durham, North Carolina, United States, 27710