Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study

Not Applicable

Completed

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

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.

Recruitment & Eligibility

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)

Arm && Interventions

Group	Intervention	Description
Closed-loop testing, then Open-loop testing	Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)	Subjects receive Closed-loop testing, then Open-loop testing (Spinal Cord Stimulation - SCS Therapy)
Open-loop (OL) testing, then Closed-loop (CL) testing	Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)	Subjects receive Open-loop testing, then Closed-loop testing (Spinal Cord Stimulation - SCS Therapy)

Primary Outcome Measures

Name	Time	Method
The Proportion of Subjects With a Reduction in Overstimulation Sensation With SCS Using a Closed-loop Algorithm Compared With SCS in Open-loop	In-clinic testing (1 day)	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.

Secondary Outcome Measures

Name	Time	Method

Locations (9): The Ohio State University
🇺🇸
Columbus, Ohio, United States
Kettering Medical Center
🇺🇸
Kettering, Ohio, United States
Nura Research Institute
🇺🇸
Edina, Minnesota, United States
Coastal Pain and Spinal Diagnostics
🇺🇸
Carlsbad, California, United States
Lakewalk Surgery Center
🇺🇸
Duluth, Minnesota, United States
Twin Cities Pain Clinic
🇺🇸
Edina, Minnesota, United States
Premier Pain Treatment Institute
🇺🇸
Mount Orab, Ohio, United States
Innovative Pain Center
🇺🇸
Watertown, South Dakota, United States
Center for Interventional Pain and Spine
🇺🇸
Lancaster, Pennsylvania, United States