90 Participants Needed

Spinal Cord Stimulation for Chronic Pain

(MOPPStim Trial)

JK
AB
Overseen ByAnuj Bhatia, MD FRCPC
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Health Network, Toronto
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that your pain should be refractory (not responding) to conventional medical management tried for at least 3 months, which suggests you may continue your current medications if they are not effective.

What data supports the effectiveness of the treatment Spinal Cord Stimulation for Chronic Pain?

Research shows that spinal cord stimulation (SCS) has been effective in managing chronic pain, especially neuropathic pain (pain from nerve damage), with many patients experiencing long-term relief. Additionally, transcutaneous spinal cord stimulation (tSCS) has been used to aid motor recovery in spinal cord injury patients, suggesting its potential in modulating nerve activity.12345

Is spinal cord stimulation safe for humans?

Spinal cord stimulation (SCS) is generally considered safe for treating chronic pain, with long-term safety data available from real-world evaluations. However, while complications are well documented, the risk of spinal cord injury during electrode implantation is not fully known.36789

How is spinal cord stimulation different from other treatments for chronic pain?

Spinal cord stimulation (SCS) is unique because it uses electrical impulses to alter pain signals before they reach the brain, which can be done through implanted electrodes (epidural) or non-invasive methods (transcutaneous). This approach is different from medications or surgeries, as it directly targets the spinal cord to manage pain without the need for drugs or destructive procedures.1341011

Research Team

AB

Anuj Bhatia, MD FRCPC

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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.

Inclusion Criteria

You have had ongoing pain that hasn't improved with regular treatments for at least 3 months.
You have pain rated higher than 3 out of 10 and a disability score higher than 40 out of 100.
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.

Exclusion Criteria

Pregnancy
You have instability in your spine that can be seen in certain X-rays.
You are currently involved in legal issues related to the pain.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SCS Trial

Participants undergo a percutaneous trial of SCS with different modes: PB-SCS, placebo, and PF-SCS

12 days
Daily visits for 12 days

Post-Trial Assessment

Neuroimaging and psychophysical testing conducted at the end of the SCS trial

1 day

Implantation and Follow-up

Participants who respond well to the trial receive SCS implantation and are monitored for 6 months

6 months
Regular follow-up visits

Treatment Details

Interventions

  • Spinal Cord Stimulation
Trial OverviewThe 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.
Participant Groups
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).

Spinal Cord Stimulation is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Spinal Cord Stimulation for:
  • Failed back surgery syndrome (FBSS)
  • Adhesive arachnoiditis
  • Peripheral causalgia/neuropathy
  • Reflex sympathetic dystrophy (RSD)
  • Phantom limb/stump pain
  • Ischemic pain of vascular origin
  • Complex regional pain syndrome
  • Pain after an amputation
  • Visceral abdominal pain and perineal pain
🇪🇺
Approved in European Union as Spinal Cord Stimulation for:
  • Chronic pain
  • Neuropathic pain
  • Spinal cord injury pain
  • Failed back surgery syndrome (FBSS)
  • Adhesive arachnoiditis
  • Peripheral causalgia/neuropathy
  • Reflex sympathetic dystrophy (RSD)
🇨🇦
Approved in Canada as Spinal Cord Stimulation for:
  • Chronic pain
  • Neuropathic pain
  • Spinal cord injury pain
  • Failed back surgery syndrome (FBSS)
  • Adhesive arachnoiditis
  • Peripheral causalgia/neuropathy
  • Reflex sympathetic dystrophy (RSD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials
1,555
Recruited
526,000+

MSH-UHN AMO Innovation Fund

Collaborator

Trials
3
Recruited
240+

Findings from Research

In a study involving seven patients with traumatic paraplegia and chronic pain, six patients reported good to very good outcomes from epidural electrical stimulation over follow-up periods of up to six years.
The positive effects on chronic pain suggest that epidural electrical stimulation should be considered as a treatment option before resorting to more invasive surgical procedures.
Experience with spinal cord stimulation (SCS) in the management of chronic pain in a traumatic transverse lesion syndrome.Buchhaas, U., Koulousakis, A., Nittner, K.[2019]
In a pilot study involving 7 individuals with chronic spinal cord injury, the use of transcutaneous electrical spinal cord stimulation (TSCS) combined with functional training led to improvements in upper and lower extremity function, with all participants showing progress on the Capabilities of Upper Extremity Test (CUE-T).
Notably, two participants improved their ASIA impairment scale classification, and five individuals experienced enhanced sensation, demonstrating that TSCS can facilitate recovery even after a plateau in rehabilitation progress, without any serious adverse events.
Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury.Tefertiller, C., Rozwod, M., VandeGriend, E., et al.[2022]
Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.
The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.
Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review.Taylor, C., McHugh, C., Mockler, D., et al.[2022]

References

Experience with spinal cord stimulation (SCS) in the management of chronic pain in a traumatic transverse lesion syndrome. [2019]
Transcutaneous Electrical Spinal Cord Stimulation to Promote Recovery in Chronic Spinal Cord Injury. [2022]
Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]
Optimizing sensory fiber activation during cervical transcutaneous spinal stimulation using different electrode configurations: A computational analysis. [2022]
[Spinal cord stimulation in chronic neuropathic pain]. [2016]
Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. [2019]
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]
Prospective Evaluation of Patient Usage of Above and Below Threshold Waveforms With Traditional Spinal Cord Stimulation Devices. [2022]
The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Effects of Tonic Spinal Cord Stimulation on External Mechanical and Thermal Stimuli Perception Using Quantitative Sensory Testing: A Multicenter Stimulation ON-OFF Study on Chronic Pain Patients. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
Use of observational mechanical gateway connector in spinal cord stimulation trials. [2011]