Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)
Key facts
- Who runs it
- Nandan Lad, M.D., Ph.D.
- Where
- Durham, United StatesSee the site
- Trial code
- Status
- Active, not recruiting
- People taking part
- 25 people enrolled
- Started
- 30 Dec 2021
- Expected to end
- 30 Jun 2028
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- EES on
- EES off
- Record updated
- 4 June 2026
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- 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
Who cannot take part
- Active drug or alcohol abuse
- Patient deemed not medically stable for surgery
- Active infection
- Comorbid psychosis or psychotic disorder
- 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
- Untreated, clinically significant depression
- 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
Where in United States
- Duke University Health SystemsDurham, United StatesNo longer taking part
About the trial
What the trial wants to find out
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 Stimulation (EES), will be utilized along with conventional medical management (CMM) or CMM alone. Participation in this research study is expected to last approximately 24 months. All subjects will be evaluated and proceed with implantation of two SCS devices- one tailored based on the individual's SCI for the treatment of neuropathic pain of trunk and limb and a second near the bottom of the spinal cord (conus region) to study the impact on motor, sensory, bowel/bladder outcomes. All patients will also continue receiving CMM, such as medications and physical therapy.
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Participating subjects will be allocated to one of two treatment groups:
1. Placebo arm: SCS OFF + CMM. Under the direction of the study physician, the patient may receive a variety of treatments, such as medications and various forms of rehabilitation. 2. Treatment arm: SCS ON + CMM. The study treatment Spinal Cord Stimulation [SCS]: the study physician will perform a trial procedure to see if the study procedure works for the patient and may implant a permanent device if it is successful. There is a temporary trial procedure, or a "test drive," which usually lasts 5-7 days. If this is successful, patients will discuss a more permanent implant. This study involves the concurrent placement of two SCS devices (one focused on pain and the second for rehabilitation).
For three months, treatment group subjects will have the SCS turned on and will have rehabilitation as part of their CMM. Participants in the placebo arm will have their SCS remain off and will undergo CMM with rehabilitation therapy similar to the treatment group. Neither the subjects nor the treatment team will know which patients are in the treatment or placebo arm.
At the end of three months, the study group will be revealed and the placebo group subjects will be allowed to crossover and have their SCS turned on. Rehabilitation visits may be remote and the study duration is approximately 24 months. There may be additional blood tests and clinical exams to collect data on the effectiveness of the therapy. Data at follow-up visits will be compared to the subjects' baseline data and that of the control group at the respective visits.
The 2 groups in the trial
- EES onTreatment being tested
Patients will undergo epidural electrical stimulation (EES) and be allocated 1:1 to EES on.The patient and their family will be formally blinded to treatment assignment. The provider, research team, biostatistician and programming team will be unblinded to treatment assignments.
- EES offPlacebo, for comparison
Patients will undergo epidural electrical stimulation (EES) and allocated 1:1 to EES off.The patient and their family will be formally blinded to treatment assignment. The provider, research team, biostatistician and programming team will be unblinded to treatment assignments. Those in the EES off category will have their EES turned on at the 9-month time point.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Feasibility of Epidural Electrical Stimulation (EES) for Improving Pain and Rehabilitation Outcomes in Patients With Spinal Cord Injury (SCI)
- Record updated
- 4 June 2026