Clinical Characterization of Burst Spinal Cord Stimulation for Chronic Pain Management

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

Recently a new form of spinal cord stimulation therapy called burst spinal cord stimulation (Burst-SCS) is available to treat chronic pain. The goal of this study is to learn more about how Burst-SCS works to reduce chronic pain. The study will examine chronic pain patients who have been deemed candidates for Burst-SCS therapy, and who have already been selected to receive a temporary externalized trial of Burst-SCS from their own doctors as part of their standard clinical care for chronic pain management. During the study, participants will be asked to complete a variety of evaluations at certain time points. In addition, there will be a randomized, double blind, crossover phase, where the particular effects of Burst-SCS and sham SCS will be evaluated. The device used to deliver Burst-SCS and sham SCS is the St. Jude Medical Invisible Trial System.

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

• Men or women with chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with any of the following: failed back surgery syndrome and intractable low back and leg pain, and for whom Burst-SCS has been recommended as a treatment option

• Candidates who can speak, read, and understand English

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Scott Lempka, PhD
NeuromodulationLab@med.umich.edu
(734) 647-9052
Time Frame
Start Date: 2019-03-12
Estimated Completion Date: 2026-06
Participants
Target number of participants: 20
Treatments
Other: Burst-SCS/sham SCS
First, participants will receive clinically-effective Burst-SCS per their standard of care. Study evaluations will be completed prior to and after stimulation. Then, participants will have their stimulation adjusted to receive sham (no) SCS. Study evaluations will be completed prior to and after this sham.
Other: Sham SCS/Burst-SCS
First, participants will receive sham (no) SCS. Study evaluations will be completed prior to and after this sham. Then, participants will have their stimulation adjusted to receive clinically-effective Burst-SCS per their standard of care. Study evaluations will be completed prior to and after stimulation.
Authors
Vishwanath Sankarasubramanian
Related Therapeutic Areas
Sponsors
Leads: University of Michigan
Collaborators: National Institutes of Health (NIH)

This content was sourced from clinicaltrials.gov