Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study

Study Overview
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Brief Summary
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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.

Detailed Description
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This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this non-applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-loop testing, then Closed-loop testing<br>Subjects receive Open-loop testing, then Closed-loop testing (Spinal Cord Stimulation - SCS Therapy) | Device: Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)<br>* SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm<br>|
| Experimental: Closed-loop testing, then Open-loop testing<br>Subjects receive Closed-loop testing, then Open-loop testing (Spinal Cord Stimulation - SCS Therapy) | Device: Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)<br>* SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects with a reduction in overstimulation sensation with SCS using a closed-loop algorithm compared with SCS in open-loop | For every overstimulation sensation brought about by protocol-prescribed activities, subjects will rate the intensity of the sensation using a 5-point Likert scale. The average intensity score during OL and CL periods will be calculated for each subject. If the average intensity score during CL period is less than that from the OL period, the subject is considered as a subject with a reduction in overstimulation sensation during CL vs. OL period. The primary endpoint is the proportion of subjects with a reduction in overstimulation sensation among subjects who have in-clinic testing. | In-clinic testing (1 day) |