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Search / Trial NCT03718325

Burst Spinal Cord Stimulation (Burst-SCS) Study

Launched by UNIVERSITY OF MICHIGAN · Oct 23, 2018

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Burst Scs Chronic Pain Spinal Cord Stimulation

ClinConnect Summary

The Burst Spinal Cord Stimulation (Burst-SCS) Study is looking at a new treatment for people with chronic pain, especially those who have not found relief after back surgery. This study aims to understand how Burst-SCS works to help reduce pain for patients who have been recommended this therapy by their doctors. Participants in the study will already be set to try out the Burst-SCS device temporarily. They will take part in assessments at specific times to track their progress and will also experience both the actual Burst-SCS treatment and a placebo (which is a treatment that doesn't have the active component) to see how each affects their pain.

To join the study, candidates must be adults aged 65 to 74 who are experiencing ongoing pain in their back or limbs and have been suggested for Burst-SCS therapy. It's important that they can understand and communicate in English. However, pregnant individuals or those unable to follow study instructions may not be eligible. Participants can expect regular evaluations throughout the study, and their experiences will contribute valuable information about this promising pain management option.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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
  • Exclusion Criteria:
  • Subjects who are pregnant- as determined by verbal report or chart review
  • Subjects with current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail. Exceptions, including brief and/or occasional use, may be permissible at the discretion of the principal investigator
  • Subjects who are unable or unwilling to cooperate with clinical testing
  • Subjects having any impairment, activity or situation that, in the judgement of the study coordinator or PI, would prevent satisfactory completion of the study protocol

About University Of Michigan

The University of Michigan, a leading academic institution renowned for its commitment to advancing healthcare and medical research, serves as a prominent clinical trial sponsor. With a robust infrastructure that supports innovative research initiatives, the university leverages its multidisciplinary expertise to conduct a wide array of clinical trials aimed at improving patient outcomes and advancing medical knowledge. Through its state-of-the-art facilities and collaborative environment, the University of Michigan fosters partnerships between researchers, clinicians, and industry leaders, ensuring the development of cutting-edge therapies and interventions that address pressing health challenges.

Locations

Ann Arbor, Michigan, United States

Patients applied

0 patients applied

Trial Officials

Scott Lempka, PhD

Principal Investigator

University of Michigan

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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