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OpenTrials
Completed

NCT Number: NCT06499220

Electrically Evoked Compound Action Potentials Human Observation Medtronic System Study (ECHO-MDT)

This is a prospective, multi-center, non-significant risk IDE study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system. comprised of Medtronic hardware or off the shelf hardware, which uses recorded waveforms to adjust stimulation amplitude.

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coastal Pain and Spinal Diagnostics, Carlsbad, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 22 years of age or older
  • Candidate for or undergoing Medtronic SCS device trial for labeled indication*
  • 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 *Candidate for or undergoing 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.

Exclusion criteria

  • Implanted electrical cardiac device (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)
  • Currently diagnosed with a disease that may confound ability to evoke compound action potentials, e.g. multiple sclerosis, as determined by the investigator
  • 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")

Treatment and study plan

Spinal cord stimulator

Device

Spinal Cord Stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs.

Primary outcomes

  1. Collection of ECAP data (sensing configurations, stimulation parameters eliciting ECAPs, control policies/algorithms for recording ECAPs) via the research system.

    Time frame: 1 hour to 72 hours

    The ECAP data collected is prototype system/device information for development of a closed loop system.

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Acronym: ECHO-MDT

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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