Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study

NCT04765735 | Completed Results DMC FDA Device

• 1 other identifier: MDT19024
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 9

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

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

EXPERIMENTAL

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)

Closed-loop testing, then Open-loop testing

EXPERIMENTAL

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)

Interventions

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

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

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

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (9)

Coastal Pain and Spinal Diagnostics

Carlsbad, California, 92009, United States

Location

Lakewalk Surgery Center

Duluth, Minnesota, 55805, United States

Location

Nura Research Institute

Edina, Minnesota, 55435, United States

Location

Twin Cities Pain Clinic

Edina, Minnesota, 55439, United States

Location

The Ohio State University

Columbus, Ohio, 43203, United States

Location

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

Premier Pain Treatment Institute

Mount Orab, Ohio, 45154, United States

Location

Center for Interventional Pain and Spine

Lancaster, Pennsylvania, 17601, United States

Location

Innovative Pain Center

Watertown, South Dakota, 57201, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Janelle Blum
• Organization: Medtronic

janelle.blum@medtronic.com

262-289-8419

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: February 23, 2021
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: February 26, 2024
• Results First Posted: February 26, 2024

Record last verified: 2024-02

Locations

US (9)