Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation
MOPPStim
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 31, 2018
CompletedFirst Posted
Study publicly available on registry
February 25, 2019
CompletedStudy Start
First participant enrolled
May 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
January 15, 2026
January 1, 2026
8.6 years
December 31, 2018
January 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Changes in neuronal activity with the novel PF-SCS modes as detected by fMRI and MEG
12 days after the initiation of the SCS trials )
Changes in neuronal activity with the novel PF-SCS modes as detected by fMRI and MEG
6 months after the initiation of the SCS implants
To measure long-term outcomes of novel PF-SCS modes including intensity and quality of pain, physical and psychological functioning, and patients' global impression of change
6 months after the initiation of the SCS implants.
Changes in sensory threshold with the novel PF-SCS modes as detected by QST
6 months after the initiation of the SCS implants
Secondary Outcomes (4)
To measure incidence of more than 50% reduction in pain intensity scores in patients with NP syndromes with novel modes of SCS
Six months after implantation.
To correlate data on physical activity as measured by an accelerometer during trials of novel SCS modes with data obtained from validated questionnaires
12 days after the initiation of the SCS trial
To correlate data on sleep as measured by an accelerometer during trials of novel SCS modes with data obtained from validated questionnaires
12 days after the initiation of the SCS trial
To measure incidences of analgesic failure (as indicated with less than 50% reduction in pain intensity scores) and adverse effects of PF-SCS
Six months after implantation.
Study Arms (1)
Spinal Cord Stimulation
EXPERIMENTALAt baseline, the following data will be recorded: standard-of-care questionnaire scores, neuroimaging (fMRI, MEG), psychophysical testing (QST), accelerometer sleep and activity data. The trial will proceed as follows: Day 1-4: Paresthesia-based SCS (PB-SCS) Day 5-8: No SCS (placebo) Day 9-12: PF-SCS Neuroimaging and psychophysical testing will be conducted at the end of the trial, and will be assessed 6-months post-implantation of the SCS device along with adverse effects. A decision to implant the SCS system will be made based on reduction of patient pain intensity by 50% in PB-SCS and/or PF-SCS modes, but not with placebo SCS. Based on the response in the trial, the patient will either not be a candidate for an SCS implant, or they will receive one of the four modes upon implantation (PB-SCS, or one of the three PF-SCS: Burst, High Frequency, High Density).
Interventions
Paresthesia-based SCS(PB-SCS), with stimulating frequencies between 30 to 80 Hz that confer a tingling sensation. Three different paresthesia-free SCS (PF-SCS) modes that use frequencies in the range of 400-10,000 Hz include Burst, High Frequency stimulation at 1.2 kHz and High Density stimulation at 400 Hz.
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Health Network, Torontolead
- MSH-UHN AMO Innovation Fundcollaborator
Study Sites (1)
Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
Related Publications (1)
Feigin G, Dana E, Bains V, Bhatia A. Evaluating patient satisfaction and perceived accuracy in questionnaires completed before vs. during a pain clinic visit. Pain Manag. 2025 Sep;15(9):571-576. doi: 10.1080/17581869.2025.2529773. Epub 2025 Jul 7.
PMID: 40623913DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anuj Bhatia, MD FRCPC
University Health Network, Toronto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Anesthesia Chronic Pain Clinical Services
Study Record Dates
First Submitted
December 31, 2018
First Posted
February 25, 2019
Study Start
May 16, 2019
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
January 15, 2026
Record last verified: 2026-01