NCT04894734

Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI)

Recruiting now NA Last updated 19 March 2026

What this trial tests

NA trial testing EES on in Spinal Cord Injury at T1-T12 Level in 30 participants. Currently enrolling.

Timeline

30 December 2021

Primary endpoint
31 December 2026

31 October 2027

Quick facts

Lead sponsor	Nandan Lad, M.D., Ph.D.
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	30
Start date	30 December 2021
Primary completion	31 December 2026
Estimated completion	31 October 2027
Sites	1 location across United States

Drugs / interventions tested

• EES on
• EES off

Conditions studied

• Spinal Cord Injury at T1-T12 Level — all drugs for Spinal Cord Injury at T1-T12 Level →
• Traumatic Thoracic Spinal Cord Contusion — all drugs for Traumatic Thoracic Spinal Cord Contusion →
• Thoracic Spinal Cord Trauma — all drugs for Thoracic Spinal Cord Trauma →
• Traumatic Thoracic Spinal Cord Laceration — all drugs for Traumatic Thoracic Spinal Cord Laceration →

Sponsor

Nandan Lad, M.D., Ph.D.

Who can join

Adults 18 to 80, any sex, with Spinal Cord Injury at T1-T12 Level or Traumatic Thoracic Spinal Cord Contusion. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Implanted spinal neuromodulation interventions for chronic pain in adults.
   O'Connell NE, Ferraro MC, Gibson W, Rice AS, et al · · 2021 · cited 43× · PMID 34854473 · DOI 10.1002/14651858.cd013756.pub2
2. Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
   Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710
3. Spinal Cord Stimulation for Pain Management Following Spinal Cord Injury: A Systematic Review.
   Gallacher DM, Suarez M, Jevotovsky DS, Oehlermarx W, et al · · 2026 · PMID 41938223 · DOI 10.2147/jpr.s573333
4. Study Protocol: Single-Blinded, Controlled, Clinical Trial Evaluating the Feasibility of Spinal Cord Stimulation for Improving Neuropathic Pain and Rehabilitation Outcomes in Patients With Thoracic Spinal Cord Injury.
   Futch BG, Venkatraman V, Smith A, Spell AW, et al · · 2025 · PMID 41163991 · DOI 10.1227/neuprac.0000000000000135