Neuropathic PainMOPPStimNCT03852381
Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation
A study testing Spinal Cord Stimulation in people with Neuropathic Pain and Chronic Pain, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Neuropathic Pain, Chronic Pain
- What is being tested?
- Spinal Cord Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 16 May 2019to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 10Show fewer
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Anuj Bhatia, MD FRCPC, (416) 603 5800 ext. 2308, anuj.bhatia@uhn.ca
Danielle Alvares, (416) 603 5800 ext. 3517, danielle.alvares@uhn.ca
About this study
Official title: Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation in Patients With Persistent Neuropathic Pain: the MOPPStim Study
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.
Read the detailed description
Over 7 million Canadians suffer from chronic pain with 1 in 4 patients having neuropathic pain (NP), a condition caused by injury to nerves in the body. NP tends to have an extremely unpleasant character, severe intensity, and a persistent unremitting course. Conventional medical management (CMM) is often ineffective in relieving NP in majority of these patients. Paresthesia-Based Spinal Cord Stimulation (PB-SCS) has been used to treat NP but it has limitations in terms of preserving analgesic benefit and it is often associated with adverse effects. Recently introduced Paresthesia-Free SCS (PF-SCS), available at all tertiary level pain centers, has the potential to overcome these limitations but knowledge gaps remain in understanding and applying this modality.
The study design will be a prospective, exploratory study with randomization of order of no stimulation with novel modes of PF-SCS during the SCS trial and blinding of subjects (as per clinical standard of care) and outcome assessors. Participants with appropriate indications for trial of SCS with novel paresthesia-free modes will be enrolled. Baseline demographic and pain-related data including opioid intake in Oral Morphine Equivalents Per day in mg (OMED) will be collected. Pre-SCS trial neuroimaging (fMRI, MEG) and QST will be performed to establish parameters for future comparisons. Data on physical activity and sleep will be collected using actigraphy, as per standard of care. Data on pain and its related domains will be collected using validated questionnaires on the Manage My Pain app, in which all questionnaires administered are part of the patient's clinical standard of care. Ninety subjects will undergo a percutaneous trial of SCS that will last 12 days and the trial will be divided into three phases. All subjects will trial a conventional paresthesia-based SCS mode in the first four days of the trial. Subjects will then proceed the next four days (day 5-8) with no (placebo) stimulation, followed by one of the three novel PF-SCS modes (Burst, High Frequency, High Density) for the last 4 days of the trial. This process is currently adopted for all patients receiving SCS as standard of care. Neuroimaging (fMRI, MEG) and QST will be performed at the end of the SCS trial. Subjects who achieve significant reduction in pain, disability and sleep disturbance questionnaire scores with one of the novel PF-SCS modes will be offered percutaneous implantation of SCS system 4 to 6 weeks after the end of the trial using the novel PF-SCS mode they experienced during the trial. MEG and QST will be performed and data from validated questionnaires on the Manage My Pain app will be collected at 6 months after implantation.
Use of fMRI (functional Magnetic Resonance Imaging), MEG (Magnetoencephalography), and QST (Quantitative Sensory Testing) in this study will help improve understanding of the alteration in brain in NP and the analgesic action of PB/PF-SCS. Validation of wearable technology and of app-based digital platforms will allow these available but infrequently-used modalities to improve success of analgesic treatments in patients with chronic pain. Healthcare systems will benefit through efficient use of resources to treat chronic pain made possible by understanding what works, who does it work for, and how to predict analgesic benefit.
- Conditions
- Neuropathic Pain, Chronic Pain
- Being tested
- Spinal Cord Stimulation
- Keywords
- Spinal Cord Stimulation, Burst Stimulation, High Frequency Stimulation, High Density Stimulation, fMRI, MEG, QST
- Medical subject headings
- Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Stimulation | Experimental | At 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). Receives: Device: Spinal Cord Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in neuronal activity with the novel PF-SCS modes as detected by fMRI and MEG
Measured: 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
Measured: 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
Measured: 6 months after the initiation of the SCS implants.
Changes in sensory threshold with the novel PF-SCS modes as detected by QST
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Six months after implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start16 May 2019
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- MSH-UHN AMO Innovation Fund
- Responsible party
- Principal investigator, Anuj Bhatia, University Health Network, Toronto
- Investigators
- Anuj Bhatia, MD FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852381
- Sponsor's protocol ID
- 18-5864
- Acronym
- MOPPStim
- Status last verified
- Jan 2026
- First submitted
- 31 Dec 2018
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 40623913
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation in Patients With Persistent Neuropathic Pain: the MOPPStim Study
- ClinicalTrials.gov ID
- NCT03852381
- Acronym / sponsor ID
- MOPPStim / 18-5864
- Conditions
- Neuropathic Pain, Chronic Pain
- Keywords
- Spinal Cord Stimulation, Burst Stimulation, High Frequency Stimulation, High Density Stimulation, fMRI, MEG, QST
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- MSH-UHN AMO Innovation Fund
- Study start
- 16 May 2019 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Over 7 million Canadians suffer from chronic pain with 1 in 4 patients having neuropathic pain (NP), a condition caused by injury to nerves in the body. NP tends to have an extremely unpleasant character, severe intensity, and a persistent unremitting course. Conventional medical management (CMM) is often ineffective in relieving NP in majority of these patients. Paresthesia-Based Spinal Cord Stimulation (PB-SCS) has been used to treat NP but it has limitations in terms of preserving analgesic benefit and it is often associated with adverse effects. Recently introduced Paresthesia-Free SCS (PF-SCS), available at all tertiary level pain centers, has the potential to overcome these limitations but knowledge gaps remain in understanding and applying this modality.
The study design will be a prospective, exploratory study with randomization of order of no stimulation with novel modes of PF-SCS during the SCS trial and blinding of subjects (as per clinical standard of care) and outcome assessors. Participants with appropriate indications for trial of SCS with novel paresthesia-free modes will be enrolled. Baseline demographic and pain-related data including opioid intake in Oral Morphine Equivalents Per day in mg (OMED) will be collected. Pre-SCS trial neuroimaging (fMRI, MEG) and QST will be performed to establish parameters for future comparisons. Data on physical activity and sleep will be collected using actigraphy, as per standard of care. Data on pain and its related domains will be collected using validated questionnaires on the Manage My Pain app, in which all questionnaires administered are part of the patient's clinical standard of care. Ninety subjects will undergo a percutaneous trial of SCS that will last 12 days and the trial will be divided into three phases. All subjects will trial a conventional paresthesia-based SCS mode in the first four days of the trial. Subjects will then proceed the next four days (day 5-8) with no (placebo) stimulation, followed by one of the three novel PF-SCS modes (Burst, High Frequency, High Density) for the last 4 days of the trial. This process is currently adopted for all patients receiving SCS as standard of care. Neuroimaging (fMRI, MEG) and QST will be performed at the end of the SCS trial. Subjects who achieve significant reduction in pain, disability and sleep disturbance questionnaire scores with one of the novel PF-SCS modes will be offered percutaneous implantation of SCS system 4 to 6 weeks after the end of the trial using the novel PF-SCS mode they experienced during the trial. MEG and QST will be performed and data from validated questionnaires on the Manage My Pain app will be collected at 6 months after implantation.
Use of fMRI (functional Magnetic Resonance Imaging), MEG (Magnetoencephalography), and QST (Quantitative Sensory Testing) in this study will help improve understanding of the alteration in brain in NP and the analgesic action of PB/PF-SCS. Validation of wearable technology and of app-based digital platforms will allow these available but infrequently-used modalities to improve success of analgesic treatments in patients with chronic pain. Healthcare systems will benefit through efficient use of resources to treat chronic pain made possible by understanding what works, who does it work for, and how to predict analgesic benefit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Stimulation | Experimental | Device: Spinal Cord StimulationAt 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord StimulationParesthesia-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. | Device | Spinal Cord Stimulation |
Primary outcome
Changes in neuronal activity with the novel PF-SCS modes as detected by fMRI and MEG
Time frame: 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
Time frame: 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
Time frame: 6 months after the initiation of the SCS implants.
Changes in sensory threshold with the novel PF-SCS modes as detected by QST
Time frame: 6 months after the initiation of the SCS implants
4 secondary outcomes
To measure incidence of more than 50% reduction in pain intensity scores in patients with NP syndromes with novel modes of SCS
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Six months after implantation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Derived from this study: PubMed 40623913Feigin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anuj Bhatia, MD FRCPC principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulation in people with Neuropathic Pain and Chronic Pain, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anuj Bhatia, MD FRCPC ((416) 603-5800 ext. 6136, anuj.bhatia@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in neuronal activity with the novel PF-SCS modes as detected by fMRI and MEG (time frame: 12 days after the initiation of the SCS trials )). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03852381, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.