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

NCT ID: NCT06499220

Last Updated: 2024-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2023-10-16

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

ECAP Recording

Group Type: EXPERIMENTAL

Spinal Cord Stimulator

Intervention Type: DEVICE

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

Interventions

Spinal Cord Stimulator

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

Intervention Type: DEVICE

Eligibility Criteria

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")

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedtronicNeuro

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Coastal Pain and Spinal Diagnostics

Carlsbad, California, United States

MercyOne Des Moines Medical Center

Des Moines, Iowa, United States

Nura Research Institute

Edina, Minnesota, United States

Twin Cities Pain Clinic

Edina, Minnesota, United States

iSpine Pain Physicians

Maple Grove, Minnesota, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Kettering Health

Kettering, Ohio, United States

Premier Pain Treatment Institute

Mount Orab, Ohio, United States

Center for Interventional Pain and Spine

Lancaster, Pennsylvania, United States

Rockefeller Neuroscience Institute West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

MDT19014

Identifier Type: -

Identifier Source: org_study_id