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Trial record 1 of 4 for:    ECHO MAC
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Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study (ECHO-MAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04765735
Recruitment Status : Completed
First Posted : February 21, 2021
Last Update Posted : November 11, 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

Detailed Description:
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this non-applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 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
Actual Primary Completion Date : June 29, 2021
Actual Study Completion Date : June 29, 2021

Resource links provided by the National Library of Medicine


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.



Information from the National Library of Medicine

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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


Locations
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United States, California
Coastal Pain and Spinal Diagnostics
Carlsbad, California, United States, 92009
United States, Minnesota
Lakewalk Surgery Center
Duluth, Minnesota, United States, 55805
Nura Research Institute
Edina, Minnesota, United States, 55435
Twin Cities Pain Clinic
Edina, Minnesota, United States, 55439
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43203
Kettering Medical Center
Kettering, Ohio, United States, 45429
Premier Pain Treatment Institute
Mount Orab, Ohio, United States, 45154
United States, Pennsylvania
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, United States, 17601
United States, South Dakota
Innovative Pain Center
Watertown, South Dakota, United States, 57201
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: November 11, 2021
Last Verified: November 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