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Device

Spinal Cord Stimulation for Chronic Pain (MOPPStim Trial)

N/A
Recruiting
Led By Anuj Bhatia, MD FRCPC
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Severity of pain > 3/10 on NRS and ODI score for disability >40/100
Pain refractory to conventional medical management tried for at least 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 days after the initiation of the scs trial
Awards & highlights

MOPPStim Trial Summary

This trial is testing a new way to treat chronic pain by stimulating different pathways in the spinal cord. They hope to understand the mechanisms of therapeutic benefit and identify criteria for selecting patients.

Who is the study for?
This trial is for adults aged 18-80 with chronic neuropathic pain in the back or lower limbs following lumbar spine surgery, which hasn't improved after at least 3 months of treatment. Participants should have a pain severity over 3/10 and disability score over 40/100. It's not for those with certain psychiatric conditions, pregnant women, people unable to follow the study protocol, spinal instability on X-rays, ongoing litigation related to their pain, other types of neuropathy or myopathy, previous SCS trials or implants.Check my eligibility
What is being tested?
The trial is testing Spinal Cord Stimulation (SCS) methods: traditional paresthesia-based (PB-SCS) and newer paresthesia-free (PF-SCS). It aims to understand how these treatments relieve pain using neuroimaging techniques and determine criteria for selecting patients most likely to benefit from these therapies.See study design
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, unwanted sensations due to electrical impulses (for PB-SCS), possible lead migration where the wires move from their original placement, infection risk from implantation procedure and rarely neurological damage.

MOPPStim Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have pain rated higher than 3 out of 10 and a disability score higher than 40 out of 100.
Select...
You have had ongoing pain that hasn't improved with regular treatments for at least 3 months.
Select...
Adults between 18 and 80 years old who have had ongoing, severe nerve pain in their back and/or legs for more than 3 months after having surgery on their lower spine.

MOPPStim Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 days after the initiation of the scs trial
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 days after the initiation of the scs trial for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in neuronal activity with the novel PF-SCS modes as detected by fMRI and MEG
Changes in sensory threshold with the novel PF-SCS modes as detected by QST
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
Secondary outcome measures
To correlate data on physical activity as measured by an accelerometer during trials of novel SCS modes with data obtained from validated questionnaires
To correlate data on sleep as measured by an accelerometer during trials of novel SCS modes with data obtained from validated questionnaires
Nail-Patella Syndrome
+1 more

Side effects data

From 2019 Phase 4 trial • 30 Patients • NCT03284411
10%
Device stimulation issue
3%
Inadequate analgesia
3%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spinal Cord Stimulation

MOPPStim Trial Design

1Treatment groups
Experimental Treatment
Group I: Spinal Cord StimulationExperimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal Cord Stimulation
2020
Completed Phase 4
~90

Find a Location

Who is running the clinical trial?

MSH-UHN AMO Innovation FundUNKNOWN
2 Previous Clinical Trials
152 Total Patients Enrolled
University Health Network, TorontoLead Sponsor
1,456 Previous Clinical Trials
482,783 Total Patients Enrolled
1 Trials studying Neuropathic Pain
60 Patients Enrolled for Neuropathic Pain
Anuj Bhatia, MD FRCPCPrincipal InvestigatorUniversity Health Network, Toronto
3 Previous Clinical Trials
335 Total Patients Enrolled

Media Library

Spinal Cord Stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03852381 — N/A
Neuropathic Pain Research Study Groups: Spinal Cord Stimulation
Neuropathic Pain Clinical Trial 2023: Spinal Cord Stimulation Highlights & Side Effects. Trial Name: NCT03852381 — N/A
Spinal Cord Stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03852381 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial limited to a certain age range?

"The requirements for this medical trial restrict participation to individuals aged 18-80. Meanwhile, 40 clinical trials are tailored towards minors and 480 studies offer treatments specifically designed for the elderly."

Answered by AI

Are there any open spots remaining in this clinical trial?

"Affirmative. Clinicaltrials.gov states that this clinical examination is actively seeking participants, with the first advertisement dating back to May 16th 2019 and the most recent update being on October 31st 2022. A total of 90 individuals are needed for 1 site."

Answered by AI

To whom does this experiment offer enrollment opportunities?

"This clinical trial is accepting 90 adult patients, aged between 18 and 80, who have suffered from refractory neuropathic pain in the back or lower limbs for more than 3 months due to lumbar spine surgery. To qualify for this study, a patient must present with chronic pain of at least 3/10 on NRS scale and an ODI score above 40/100 that has not improved with conventional treatments over the last three months."

Answered by AI

What is the intake size for this experiment?

"Affirmative. The details posted on clinicaltrials.gov indicate that recruitment for this study is ongoing, with the initial advertisement published on 16 May 2019 and the most recent update occurring at 31 October 2022. This trial requires 90 volunteers to be enrolled from 1 medical facility."

Answered by AI
~15 spots leftby Mar 2025