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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2019 Phase 4 trial • 30 Patients • NCT0328441110%
Device stimulation issue
3%
Inadequate analgesia
3%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spinal Cord Stimulation
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
~440
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
1,531 Previous Clinical Trials
504,232 Total Patients Enrolled
13 Trials studying Chronic Pain
12,518 Patients Enrolled for Chronic Pain
Anuj Bhatia, MD FRCPCPrincipal InvestigatorUniversity Health Network, Toronto
3 Previous Clinical Trials
335 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had ongoing pain that hasn't improved with regular treatments for at least 3 months.You have instability in your spine that can be seen in certain X-rays.You have pain rated higher than 3 out of 10 and a disability score higher than 40 out of 100.You are currently involved in legal issues related to the pain.You have ongoing nerve or muscle problems, or pain related to nerve damage (like after a stroke).You are either younger than 18 or older than 80 years old.You have participated in a previous trial or have had a spinal cord stimulation system implanted.You have had extensive surgery on your upper or lower back, have a narrowing of the spinal canal, have bleeding problems, or have an infection in your back or elsewhere in your body.You are taking more than 200 milligrams of opioid medication per day.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.You have a mental health condition that may affect how you feel pain.
Research Study Groups:
This trial has the following groups:- Group 1: Spinal Cord Stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.