Back to resultsElectrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study (ECHO-MAC)
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
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)
Sites / Locations
- Coastal Pain and Spinal Diagnostics
- Lakewalk Surgery Center
- Nura Research Institute
- Twin Cities Pain Clinic
- The Ohio State University
- Kettering Medical Center
- Premier Pain Treatment Institute
- Center for Interventional Pain and Spine
- Innovative Pain Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Open-loop testing, then Closed-loop testing
Closed-loop testing, then Open-loop testing
Arm Description
Subjects receive Open-loop testing, then Closed-loop testing (Spinal Cord Stimulation - SCS Therapy)
Subjects receive Closed-loop testing, then Open-loop testing (Spinal Cord Stimulation - SCS Therapy)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04765735
Brief Title
Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study
Acronym
ECHO-MAC
Official Title
Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study (ECHO-MAC)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
June 29, 2021 (Actual)
Study Completion Date
June 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this non-applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open-loop testing, then Closed-loop testing
Arm Type
Experimental
Arm Description
Subjects receive Open-loop testing, then Closed-loop testing (Spinal Cord Stimulation - SCS Therapy)
Arm Title
Closed-loop testing, then Open-loop testing
Arm Type
Experimental
Arm Description
Subjects receive Closed-loop testing, then Open-loop testing (Spinal Cord Stimulation - SCS Therapy)
Intervention Type
Device
Intervention Name(s)
Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)
Intervention Description
SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm
Primary Outcome Measure Information:
Title
The proportion of subjects with a reduction in overstimulation sensation with SCS using a closed-loop algorithm compared with SCS in open-loop
Description
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.
Time Frame
In-clinic testing (1 day)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Coastal Pain and Spinal Diagnostics
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Facility Name
Lakewalk Surgery Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Nura Research Institute
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Twin Cities Pain Clinic
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55439
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Premier Pain Treatment Institute
City
Mount Orab
State/Province
Ohio
ZIP/Postal Code
45154
Country
United States
Facility Name
Center for Interventional Pain and Spine
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Innovative Pain Center
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
12. IPD Sharing Statement
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Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study
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