Using spinal cord stimulation to treat pain and improve rehabilitation in spinal cord injury patients
The Feasibility of Epidural Electrical Stimulation (EES) for Improving Pain and Rehabilitation Outcomes in Patients With Spinal Cord Injury (SCI)
This study is testing if spinal cord stimulation can help reduce pain and improve recovery for people with traumatic spinal cord injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT04894734 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to evaluate the effects of spinal cord stimulation (SCS) on pain management and rehabilitation outcomes in patients with traumatic thoracic spinal cord injuries. Participants will be randomly assigned to receive either SCS combined with conventional medical management or conventional management alone. The study will last approximately 12 months, during which various clinical and neurophysiological data will be collected at multiple time points. The primary goal is to assess the impact of SCS on neuropathic pain and functional recovery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with chronic pain resulting from traumatic thoracic spinal cord injuries.
Not a fit: Patients with complete cord transection or significant comorbidities that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and rehabilitation outcomes for patients with spinal cord injuries.
How similar studies have performed: Previous studies have shown promise in using spinal cord stimulation for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects enrolled in this study must meet all of the following inclusion criteria (based on investigator judgement): 1. Traumatic, thoracic SCI 2. Chronic neuropathic pain (i.e., Pain \>3 for \> 3 months) 3. Willing and able to provide informed consent, attend required study visits, and complete required assessments/questionnaires 4. 18-80 years of age 5. 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): 1. Complete cord transection 2. Persistent spinal instability or other injury preventing ability to participate 3. Active infection 4. Comorbid psychosis or psychotic disorder 5. Untreated, clinically significant depression 6. Active drug or alcohol abuse 7. Pregnant women or women who intend to become pregnant during the duration of the study. Women of childbearing potential need a negative pregnancy test 8. Patients without symptoms of neuropathic pain \>3/10 for \> 3 months 9. Patient deemed not medically stable for surgery
Where this trial is running
Durham, North Carolina
- Duke University Health Systems — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Shivanand Lad, MD, PhD — Duke University
- Study coordinator: Allison Spell
- Email: allison.spell@duke.edu
- Phone: 919-681-4937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.