Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study (ECHO-MAC)

Medtronic

Status: Completed

Conditions: Chronic Pain

Treatments: Device: Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04765735

MDT19024

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Open-loop (OL) testing, then Closed-loop (CL) testing

Experimental group

Description:

Subjects receive Open-loop testing, then Closed-loop testing (Spinal Cord Stimulation - SCS Therapy)

Treatment:

Device: Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)

Closed-loop testing, then Open-loop testing

Experimental group

Description:

Subjects receive Closed-loop testing, then Open-loop testing (Spinal Cord Stimulation - SCS Therapy)

Treatment:

Device: Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)