Actively Recruiting
Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation
Led by University Health Network, Toronto · Updated on 2026-01-15
90
Participants Needed
1
Research Sites
450 weeks
Total Duration
On this page
Sponsors
U
University Health Network, Toronto
Lead Sponsor
M
MSH-UHN AMO Innovation Fund
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years with neuropathic pain in back or lower limbs lasting more than 3 months after lumbar spine surgery
- Neuropathic pain confirmed by DN4 score greater than 3 out of 10
- Pain severity greater than 3 out of 10 on the Numeric Rating Scale
- Disability score greater than 40 out of 100 on the Oswestry Disability Index
- Pain not relieved by conventional medical management tried for at least 3 months
You will not qualify if you...
- Age younger than 18 years or 80 years and older
- Previous trial or implantation of spinal cord stimulation system
- Contraindications to SCS including extensive thoracolumbar spine surgery, moderate-to-severe central canal stenosis, bleeding disorders, or infections
- Pregnancy
- Opioid dose greater than 200 mg oral morphine equivalents per day
- Psychiatric or psychological disorders affecting pain perception
- Inability to follow study procedures or assess treatment outcomes
- Mechanical spine instability as shown by lumbar X-rays
- Ongoing legal issues related to pain
- Presence of peripheral neuropathy, myopathy, or central neuropathic pain such as post-stroke pain
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Actively Recruiting
Research Team
A
Anuj Bhatia, MD FRCPC
CONTACT
J
Jamal Kara
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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