Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study

Chronic Pain Clinical Trial

— ECHO-MAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04765735
• Other study ID #: MDT19024
• Status: Completed
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: June 29, 2021

Study information

• Verified date: February 2024
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 29, 2021
• Est. primary completion date: June 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

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)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Coastal Pain and Spinal Diagnostics	Carlsbad	California
United States	The Ohio State University	Columbus	Ohio
United States	Lakewalk Surgery Center	Duluth	Minnesota
United States	Nura Research Institute	Edina	Minnesota
United States	Twin Cities Pain Clinic	Edina	Minnesota
United States	Kettering Medical Center	Kettering	Ohio
United States	Center for Interventional Pain and Spine	Lancaster	Pennsylvania
United States	Premier Pain Treatment Institute	Mount Orab	Ohio
United States	Innovative Pain Center	Watertown	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)