Spinal Cord Injury Research Study
Researchers at Duke University are conducting a study in adults with a thoracic spinal cord injury (affecting the upper or mid-back, T1-T12) to find out if Epidural Electrical Stimulation (EES) can improve nerve pain and rehabilitation outcomes.
Fast Facts

Thoracic Spinal Cord Injury

Experiencing Chronic Nerve Pain

Injury at Least 1 Year Ago

Conducted in Durham, NC
Study Background
Does treatment with neuromodulation improve nerve pain and rehabilitation outcomes for people with spinal cord injury?
Neuromodulation is a treatment strategy in which the goal is to stimulate the nerves in a particular way, usually using a mild electrical pulse. In this research study, we will be testing a neuromodulation treatment called Epidural Electrical Stimulation, in which a device is surgically implanted onto the spinal column. We want to find out if EES helps to lessen pain and augment rehabilitation for people with a thoracic spinal cord injury.
If you have a thoracic spinal cord injury and have been experiencing chronic pain for more than 3 months, or if you are the caregiver for someone who fits this description, click below to check eligibility for this study.
Study Background
Does treatment with neuromodulation improve nerve pain and rehabilitation outcomes for people with spinal cord injury?
Neuromodulation is a treatment strategy in which the goal is to stimulate the nerves in a particular way, usually using a mild electrical pulse. In this research study, we will be testing a neuromodulation treatment called Epidural Electrical Stimulation, in which a device is surgically implanted onto the spinal column. We want to find out if EES helps to lessen pain and augment rehabilitation for people with a thoracic spinal cord injury.
If you have a thoracic spinal cord injury and have been experiencing chronic pain for more than 3 months, or if you are the caregiver for someone who fits this description, click below to check eligibility for this study.
Additional Information
The purpose of this feasibility study is to determine if neuromodulation can be used to improve pain relief and rehabilitation in people with a spinal cord injury (SCI), as well as to further describe neurophysiological measures and clinical outcomes.
You may qualify for this study if you meet the following criteria.
Inclusion Criteria:
- Diagnosed with thoracic spinal cord injury (affecting the upper or mid-back, T1-T12)
- Experiencing chronic nerve pain
- Injury at least 1 year ago
- Medically stable enough to undergo surgical implantation of a spinal cord stimulator (SCS) and participate in rehabilitation programs
- Ages 18-80
- Pain has been occurring for at least 3 months
Exclusion Criteria:
- Pregnancy or plans to become pregnant in the near future
- Active drug or alcohol dependency
- Active infection
- Diagnosis of complete spinal cord transection (meaning the spinal cord has been fully compressed or severed, completely eliminating the brain’s ability to send signals below the point of injury)
- Current psychosis or psychotic disorder
Your participation will involve a number of in-person visits over a 2-year period, including baseline visit(s), treatment allocation visit, and study visits after 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Participants will be randomly placed in one of two treatment groups:
1. Placebo arm. Under the direction of the study physician, you may receive a variety of treatments, such as medications and various forms of rehabilitation.
2. Treatment arm. The study physician will perform a trial procedure to see if the study procedure works for you, 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, we will discuss with you 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 participants will have the SCS turned on and will have rehabilitation as part of their treatment plan. Participants in the placebo arm will have their SCS remain off and will undergo a treatment plan with rehabilitation therapy similar to the treatment group. Both groups will not know which group they are in for the 3-month period after the implant.
Compensation for participation is provided.
Visit ClinicalTrials.gov ID# NCT04894734.
Principal Investigator: Dr. Nandan Lad, MD, PhD
Contact us at 919-681-4937 / email allison.spell@duke.edu
IRB Pro00106738