Mechanisms and Outcome-Prognostication for Paresthesia-based and -free Spinal Cord Stimulation in Patients with Persistent Neuropathic Pain: the MOPPStim Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Toronto Western Hospital
RECRUITING
Toronto
Contact Information
Primary
Anuj Bhatia, MD FRCPC
anuj.bhatia@uhn.ca
(416) 603-5800
Backup
Jamal Kara
jamal.kara@uhn.ca
(416) 603-5800
Time Frame
Start Date: 2019-05-16
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 90
Treatments
Experimental: Spinal Cord Stimulation
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).
Related Therapeutic Areas
Sponsors
Leads: University Health Network, Toronto
Collaborators: MSH-UHN AMO Innovation Fund

This content was sourced from clinicaltrials.gov