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Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study | Clinical Trials | Clareo Health

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Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study

Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study (ECHO-MAC)

NCT04765735•MedtronicNeuro

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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)

Locations (9)

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

Key Dates

Start Date

February 23, 2021

Primary Completion Date

June 29, 2021

Completion Date

June 29, 2021

Last Updated

February 26, 2024

Enrollment

ACTUAL participants

Conditions

Chronic Pain

Interventions

Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)

DEVICE

Optimization of NIBS for Treatment of Addiction

NCT04379115

Opioid-use DisorderChronic Pain

View study

RECRUITINGNA

VR Mindfulness Training for Veterans With SCI

NCT06587607

Spinal Cord InjuryChronic Pain

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 26, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study

Inclusion Criteria

Exclusion Criteria

Optimization of NIBS for Treatment of Addiction

VR Mindfulness Training for Veterans With SCI

CIH Stepped Care for Co-occurring Chronic Pain and PTSD

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