Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-23

Study Completion Date

2021-06-29

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.

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Detailed Description

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Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm

Closed-loop testing, then Open-loop testing

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

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm

Interventions

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

SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm

Intervention Type DEVICE

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)

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No