NCT06390150

Midline Versus Dorsolateral Spinal Cord Stimulation for Post-surgical Neuropathic Pain

Midline Versus Dorsolateral Spinal Cord Stimulation for Post-surgical Neuropathic Pain (MIDL-SCS Trial)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Nova Scotia Health Authority · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this interventional study is to learn if dorsolateral spinal cord stimulation (DL-SCS) can treat focal post-surgical, medically refractory neuropathic pain. The main question it aims to answer is: \- How does DL-SCS compare to traditional SCS and no treatment for treating post-surgical neuropathic pain? Participants will be asked to * trial combinations of stimulation across blocks of weeks (randomized cross-over) * rate their pain after each stimulation trial

Detailed description

Neuropathic pain resulting from injury to the somatosensory nervous system can be a persistent and debilitating condition of spontaneous and unprovoked symptoms. For patients with chronic neuropathic pain that does not respond to conservative therapy, spinal cord stimulation (SCS) may be considered. SCS has been established as an effective and sustained treatment for neuropathic pain, but may deliver treatment to more than just the pain area. Dorsolateral spinal cord stimulation (DL-SCS) may provide a more focal alternate target for spinal stimulation. The aim of this study is to investigate DL-SCS as a therapeutic option for post-surgical, medically refractory neuropathic pain. This is a prospective, randomized, double-blind controlled crossover trial to investigate the efficacy of DL-SCS and midline SCS (M-SCS) compared to sham stimulation for the diagnosis of post-surgical neuropathic pain. Each participant will be implanted with two electrodes and will crossover into each stimulation program in a randomized order to serve as their own control.

Conditions

• Pain, Postoperative
• Neuropathic Pain

Interventions

Type	Name	Description
DEVICE	Spinal Cord Stimulator	The spinal cord stimulator is an implantable pulse generator connected to electrodes with leads that stimulate the spinal cord. The device is programmed to deliver therapeutic stimulation to treat pain.

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-06-01
• Completion: 2030-07-01
• First posted: 2024-04-30
• Last updated: 2025-08-03

Locations

1 site across 1 country: Canada