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

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Spinal Cord Stimulator

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92009
      • Coastal Pain and Spinal Diagnostics
  • Iowa
    • Des Moines, Iowa, United States, 50314
      • MercyOne Des Moines Medical Center
  • Minnesota
    • Edina, Minnesota, United States, 55439
      • Twin Cities Pain Clinic
    • Edina, Minnesota, United States, 55435
      • Nura Research Institute
    • Maple Grove, Minnesota, United States, 55369
      • iSpine Pain Physicians
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical CEnter
    • Kettering, Ohio, United States, 45429
      • Kettering Health
    • Mount Orab, Ohio, United States, 45154
      • Premier Pain Treatment Institute
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17601
      • Center for Interventional Pain and Spine
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Rockefeller Neuroscience Institute West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 22 years of age or older
2. Candidate for or undergoing Medtronic SCS device trial for labeled indication*
3. Willing and able to provide signed and dated informed consent
4. Capable of comprehending and consenting in English
5. 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:

1. Implanted electrical cardiac device (e.g., pacemaker, defibrillator)
2. 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)
3. Currently diagnosed with a disease that may confound ability to evoke compound action potentials, e.g. multiple sclerosis, as determined by the investigator
4. Pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
5. Has untreated major psychiatric comorbidity, as determined by the investigator or designee
6. Trialed with a permanent implant lead and extension ("buried lead trial")

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ECAP Recording	Device: Spinal Cord Stimulator; Spinal Cord Stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of ECAP data (sensing configurations, stimulation parameters eliciting ECAPs, control policies/algorithms for recording ECAPs) via the research system.	The ECAP data collected is prototype system/device information for development of a closed loop system.	1 hour to 72 hours

Collaborators and Investigators

• Sponsor: MedtronicNeuro

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): October 16, 2023
• Study Completion (Actual): October 16, 2023

Study Registration Dates

• First Submitted: June 18, 2024
• First Submitted That Met QC Criteria: July 8, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 8, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: MDT19014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes