NCT03852381 Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation
| NCT ID | NCT03852381 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Neuropathic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2019-05-16 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 90 participants in total. It began in 2019-05-16 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 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 2. Severity of pain \> 3/10 on NRS and ODI score for disability \>40/100; and 3. Pain refractory to conventional medical management tried for at least 3 months. Exclusion Criteria: 1. Age \< 18 or age ≥ 80 years; 2. Previous trial or implantation of SCS system; 3. Procedural contraindications to SCS including extensive thoracolumbar spine surgery, moderate-to-severe central canal stenosis, coagulopathy, local or systemic infection; 4. Pregnancy; 5. Opioid dose \> 200 mg OMED; 6. Psychiatric or psychological disorder likely to impact perception of pain; 7. Inability to comply with the study interventions or evaluate treatment outcomes; 8. Mechanical spine instability as per flexion/extension lumbar X-rays; 9. Ongoing litigation issues related to the pain; and 10. Concomitant peripheral neuropathy or myopathy or central neuropathic pain (e.g. post-stroke pain).
Contact & Investigator
Anuj Bhatia, MD FRCPC
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT03852381 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Neuropathic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03852381 currently recruiting?
Yes, NCT03852381 is actively recruiting participants. Contact the research team at anuj.bhatia@uhn.ca for enrollment information.
Where is the NCT03852381 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT03852381 clinical trial?
NCT03852381 is sponsored by University Health Network, Toronto. The principal investigator is Anuj Bhatia, MD FRCPC at University Health Network, Toronto. The trial plans to enroll 90 participants.