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

Not Applicable

Completed

• Conditions: Chronic Pain
• Interventions: Device: Spinal Cord Stimulator

• Registration Number: NCT06499220
• Lead Sponsor: MedtronicNeuro

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-30
• Primary Completion: 2023-10-16
• Study Completion: 2023-10-16
• Study First Submitted: 2024-06-18
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ECAP Recording	Spinal Cord Stimulator	-

Primary Outcome Measures

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

Trial Locations

Locations (10)

Twin Cities Pain Clinic; 🇺🇸 Edina, Minnesota, United States

iSpine Pain Physicians; 🇺🇸 Maple Grove, Minnesota, United States

Nura Research Institute; 🇺🇸 Edina, Minnesota, United States

Coastal Pain and Spinal Diagnostics; 🇺🇸 Carlsbad, California, United States

MercyOne Des Moines Medical Center; 🇺🇸 Des Moines, Iowa, United States

Premier Pain Treatment Institute; 🇺🇸 Mount Orab, Ohio, United States

Center for Interventional Pain and Spine; 🇺🇸 Lancaster, Pennsylvania, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Kettering Health; 🇺🇸 Kettering, Ohio, United States

Rockefeller Neuroscience Institute West Virginia University; 🇺🇸 Morgantown, West Virginia, United States