Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation

Recruiting now · Not applicable

Conditions studied: Neuropathic Pain, Chronic Pain

In brief

Spinal cord stimulation (SCS) relies on stimulation of pain-relieving pathways in the spinal cord to treat chronic neuropathic pain. Traditional paresthesia-based SCS (PB-SCS) relies on providing analgesia through stimulation of spinal cord dorsal columns but it is often associated with attenuation of analgesic benefit and lack of acceptance of paresthesias. Recently introduced three different paresthesia-free (PF-SCS) modes of stimulation aim to overcome limitations of PB-SCS. Several questions regarding PB and PF SCS modes remain unanswered including the mechanisms of therapeutic benefit, criteria for selecting patients likely to benefit, and long-term outcomes. A concerted effort is required to understand and optimize utilization of SCS. This project has the twin goals of using neuroimaging techniques to understand mechanisms that underlies analgesic benefit from PB/PF-SCS modes and to identify criteria for selecting patients based on monitoring of pain and its related domains in patients undergoing SCS trials. Achieving these objectives will increase probability of analgesic benefit while minimizing adverse effects and knowledge gains from this study will be applicable to other therapies for chronic pain conditions.

Key facts

Study ID

NCT03852381

Run by

University Health Network, Toronto

People needed

90

Starts

2019-05-16

Expected to finish

2027-12-31

Last updated by the study team

2026-01-15

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults, 18 - 80 years of age, with refractory neuropathic pain (as per clinical features and DN4 score > 3/10) in back and or lower limbs for more than 3 months following lumbar spine surgery
• Severity of pain > 3/10 on NRS and ODI score for disability >40/100; and
• Pain refractory to conventional medical management tried for at least 3 months.

You may not qualify if…

• Age < 18 or age ≥ 80 years;
• Previous trial or implantation of SCS system;
• Procedural contraindications to SCS including extensive thoracolumbar spine surgery, moderate-to-severe central canal stenosis, coagulopathy, local or systemic infection;
• Pregnancy;
• Opioid dose > 200 mg OMED;
• Psychiatric or psychological disorder likely to impact perception of pain;
• Inability to comply with the study interventions or evaluate treatment outcomes;
• Mechanical spine instability as per flexion/extension lumbar X-rays;
• Ongoing litigation issues related to the pain; and
• Concomitant peripheral neuropathy or myopathy or central neuropathic pain (e.g. post-stroke pain).

Where it is running

• Toronto Western Hospital — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.