Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study

Completed · Not applicable

Conditions studied: Chronic Pain

In brief

This is a prospective, multi-center, randomized, single-blind, cross-over, non-significant risk IDE research study to evaluate the in-clinic performance of a closed-loop algorithm in Spinal Cord Stimulation (SCS) therapy with an ENS device.

Key facts

Study ID

NCT04765735

Run by

MedtronicNeuro

People needed

52

Starts

2021-02-23

Expected to finish

2021-06-29

Last updated by the study team

2024-02-26

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 22 years of age or older
• Candidate for or undergoing Medtronic SCS device trial for labeled indication - Candidate for or undergoing a Medtronic SCS device trial for labeled indication means that a clinical decision has already been made between a physician and the patient to undergo Medtronic SCS trialing to treat the patient's chronic pain. This decision is to be made prior to discussing with the patient whether to enroll in the study
• Willing and able to provide signed and dated informed consent
• Capable of comprehending and consenting in English
• Willing and able to comply with all study procedures and visits
• Clear, measurable ECAP ECAPs - If during set up of the in-clinic testing, the subject does not have a clear, measurable ECAP (>10uV amplitude obtained consistently and repeatably) they will not move forward with testing or randomization and will be considered a screen failure.

You may not qualify if…

• Implanted electrical cardiac devices (e.g., pacemaker, defibrillator)
• Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results (co-enrollment in an interventional study is only allowed when documented pre-approval is obtained from the Medtronic study manager or designee)
• Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
• Has untreated major psychiatric comorbidity, as determined by the investigator or designee
• Trialed with a permanent implant lead and extension ("buried lead trial")
• If subject is classified as vulnerable or requires a legally authorized representative (LAR)

Where it is running

• Coastal Pain and Spinal Diagnostics — Carlsbad, California, United States
• Lakewalk Surgery Center — Duluth, Minnesota, United States
• Nura Research Institute — Edina, Minnesota, United States
• Twin Cities Pain Clinic — Edina, Minnesota, United States
• The Ohio State University — Columbus, Ohio, United States
• Kettering Medical Center — Kettering, Ohio, United States
• Premier Pain Treatment Institute — Mount Orab, Ohio, United States
• Center for Interventional Pain and Spine — Lancaster, Pennsylvania, United States
• Innovative Pain Center — Watertown, South Dakota, United States

Full record on ClinicalTrials.gov

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