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RECRUITING
NCT03852381
NA

Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation

Sponsor: University Health Network, Toronto

View on ClinicalTrials.gov

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.

Official title: Mechanisms and Outcome-Prognostication for Paresthesia-based and -Free Spinal Cord Stimulation in Patients With Persistent Neuropathic Pain: the MOPPStim Study

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2019-05-16

Completion Date

2027-12-31

Last Updated

2026-01-15

Healthy Volunteers

No

Interventions

DEVICE

Spinal Cord Stimulation

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.

Locations (1)

Toronto Western Hospital

Toronto, Ontario, Canada