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

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 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.

Conditions

• Spinal Cord Injury at T1-T12 Level
• Traumatic Thoracic Spinal Cord Contusion
• Thoracic Spinal Cord Trauma
• Traumatic Thoracic Spinal Cord Laceration
• Post-Traumatic Thoracic Myelopathy
• Traumatic Thoracic Spinal Cord Myelopathy

Interventions

DEVICE

EES on

Epidural electrical stimulation (EES), also known as spinal cord stimulation (SCS), is a common FDA-approved therapy for chronic neuropathic pain of trunk and limb.

DEVICE

EES off

Epidural electrical stimulation (EES), also known as spinal cord stimulation (SCS), is a common FDA-approved therapy for chronic neuropathic pain of trunk and limb.

Sponsors & Collaborators

• Nandan Lad, M.D., Ph.D.

  lead OTHER

Principal Investigators

• Shivanand Lad, MD, PhD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-30

Primary Completion

2026-12-31

Completion

2027-10-31

FDA Device

Yes

Countries

• United States

Study Locations