Clinical trial NCT04765735: Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study
Official title: Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study (ECHO-MAC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 52
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: The Proportion of Subjects With a Reduction in Overstimulation Sensation With SCS Using a Closed-loop Algorithm Compared With SCS in Open-loop
timeFrame: In-clinic testing (1 day)
Secondary outcomes:
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Coastal Pain and Spinal Diagnostics
state: California
city: Duluth
country: United States
facility: Lakewalk Surgery Center
state: Minnesota
city: Edina
country: United States
facility: Nura Research Institute
state: Minnesota
city: Edina
country: United States
facility: Twin Cities Pain Clinic
state: Minnesota
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Mount Orab
country: United States
facility: Premier Pain Treatment Institute
state: Ohio
city: Lancaster
country: United States
facility: Center for Interventional Pain and Spine
state: Pennsylvania
city: Watertown
country: United States
facility: Innovative Pain Center
state: South Dakota
Study officials:
References: