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

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ClinicalTrials.gov Identifier: NCT04765735
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study (ECHO-MAC)
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Open-loop testing, then Closed-loop testing
Subjects receive Open-loop testing, then Closed-loop testing (Spinal Cord Stimulation - SCS Therapy)
Device: Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)
SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm

Experimental: Closed-loop testing, then Open-loop testing
Subjects receive Closed-loop testing, then Open-loop testing (Spinal Cord Stimulation - SCS Therapy)
Device: Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)
SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm




Primary Outcome Measures :
  1. The proportion of subjects with a reduction in overstimulation sensation with SCS using a closed-loop algorithm compared with SCS in open-loop [ Time Frame: In-clinic testing (1 day) ]
    For every overstimulation sensation brought about by protocol-prescribed activities, subjects will rate the intensity of the sensation using a 5-point Likert scale. The average intensity score during OL and CL periods will be calculated for each subject. If the average intensity score during CL period is less than that from the OL period, the subject is considered as a subject with a reduction in overstimulation sensation during CL vs. OL period. The primary endpoint is the proportion of subjects with a reduction in overstimulation sensation among subjects who have in-clinic testing.



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04765735


Contacts
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Contact: Stacie Hallaway 763-514-0152 stacie.hallaway@medtronic.com

Locations
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United States, California
Coastal Pain and Spinal Diagnostics Recruiting
Carlsbad, California, United States, 92009
Contact: Suzanne Nanson       suzanne@coastalpainresearch.com   
Principal Investigator: Nathan A Miller, MD         
Sub-Investigator: Ankush Bansal, MD         
Sub-Investigator: Yogesh V Patel, MD         
United States, Minnesota
Lakewalk Surgery Center Recruiting
Duluth, Minnesota, United States, 55805
Contact: Athena Davies       adavies@twu.edu   
Principal Investigator: Christopher Davies, MD         
Nura Research Institute Recruiting
Edina, Minnesota, United States, 55435
Contact: Andrea Mohs       amohs@nuraclinics.com   
Principal Investigator: David Schultz, MD         
Sub-Investigator: Scott Stayner, MD, PhD         
Twin Cities Pain Clinic Recruiting
Edina, Minnesota, United States, 55439
Contact: Karen Trutnau       karen.trutnau@tcpain.com   
Principal Investigator: Andrew Will, MD         
Sub-Investigator: Karen Trutnau, CNP         
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43203
Contact: Alberto Uribe       Alberto.Uribe@osumc.edu   
Principal Investigator: Suren Soghomonyan, MD         
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Contact: Daniel Geyer       Daniel.Geyer@ketteringhealth.org   
Principal Investigator: Daniel Verrill, MD         
Sub-Investigator: Mark Hoeprich, MD         
Premier Pain Treatment Institute Recruiting
Mount Orab, Ohio, United States, 45154
Contact: Traci Corzatt       tcorzatt@premierpaintreatment.com   
Principal Investigator: Michael Danko, MD         
United States, Pennsylvania
Center for Interventional Pain and Spine Recruiting
Lancaster, Pennsylvania, United States, 17601
Contact: Ashley Scherer       ashleys@centerisp.com   
Principal Investigator: Michael Fishman, MD         
Sub-Investigator: Philip Kim, MD         
Sub-Investigator: Tony Vanetesse, MD         
United States, South Dakota
Innovative Pain Center Recruiting
Watertown, South Dakota, United States, 57201
Contact: Anna Walraven       awalraven@ipaincenter.com   
Principal Investigator: Patrick Retterath, MD         
Sponsors and Collaborators
MedtronicNeuro
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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT04765735    
Other Study ID Numbers: MDT19024
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: May 28, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations