Chronic PainECHO-MACNCT04765735

Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study

A study testing Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS) in people with Chronic Pain, run by MedtronicNeuro at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Chronic Pain
What is being tested?: Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 9 sitesUnited States
Study dates: 23 Feb 2021to 29 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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)

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Coastal Pain and Spinal Diagnostics
Carlsbad, California, 92009
The Ohio State University
Columbus, Ohio, 43203
Lakewalk Surgery Center
Duluth, Minnesota, 55805
Nura Research Institute
Edina, Minnesota, 55435
Twin Cities Pain Clinic
Edina, Minnesota, 55439
Kettering Medical Center
Kettering, Ohio, 45429
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, 17601
Premier Pain Treatment Institute
Mount Orab, Ohio, 45154
Innovative Pain Center
Watertown, South Dakota, 57201

Other trials in United States

About this study

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

Conditions: Chronic Pain
Being tested: Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04765735
Study group	Role	What they receive
Open-loop (OL) testing, then Closed-loop (CL) testing	Experimental	Subjects receive Open-loop testing, then Closed-loop testing (Spinal Cord Stimulation - SCS Therapy) Receives: 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) Receives: Device: Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: In-clinic testing (1 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Feb 202129 Jun 2021

First posted21 Feb 2021
Study start23 Feb 2021
Primary completion29 Jun 2021
Study completion29 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04765735
Sponsor's protocol ID: MDT19024
Acronym: ECHO-MAC
Status last verified: Feb 2024
First submitted: 18 Feb 2021
Last updated: 26 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Will A, Fishman M, Schultz D, Danko M, Verill D, Davies C, Retterath P, Miller N, Tonder L, Johanek L, Dinsmoor D, Tan Y, Franke A, Soghomonyan S. Improvements in Therapy Experience With Evoked Compound Action Potential Controlled, Closed-Loop Spinal Cord Stimulation-Primary Outcome of the ECHO-MAC Randomized Clinical Trial. J Pain. 2024 Nov;25(11):104646. doi: 10.1016/j.jpain.2024.104646. Epub 2024 Jul 31.
PubMed 39094810

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study (ECHO-MAC)
ClinicalTrials.gov ID: NCT04765735
Acronym / sponsor ID: ECHO-MAC / MDT19024
Conditions: Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Study start: 23 Feb 2021 (actual)
Primary completion: 29 Jun 2021 (actual)
Study completion: 29 Jun 2021 (actual)
First posted: 21 Feb 2021 (actual)
Results: Posted 26 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Open-loop (OL) testing, then Closed-loop (CL) testing	Experimental	Device: 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)
Closed-loop testing, then Open-loop testing	Experimental	Device: 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)

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (6 listed)

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")

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Device	Closed-loop testing, then Open-loop testing, Open-loop (OL) testing, then Closed-loop (CL) testing

Primary outcome

The Proportion of Subjects With a Reduction in Overstimulation Sensation With SCS Using a Closed-loop Algorithm Compared With SCS in Open-loop
Time frame: 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.

Results and safety

Results posted to the registry on 26 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Open-loop Testing, Then Closed-loop Testing	22	22
Closed-loop Testing, Then Open-loop Testing	20	20

Primary outcome: The Proportion of Subjects With a Reduction in Overstimulation Sensation With SCS Using a Closed-loop Algorithm Compared With SCS in Open-loop

Time frame: In-clinic testing (1 day). Count of participants. Unit: Participants

Measure	Intent-to-treat (ITT) n = 42
Value	41

Intent-to-treat (ITT): p <0.001, Binomial Exact Test

Population analysed: Intent-to-treat analysis set included all subjects who were randomized. Analysis was pre-specified in the study statistical analysis plan to report out on the total proportion of subjects with success together, regardless of the randomization sequence.

Adverse events

Time frame: The extent of exposure in this study was defined as the time from in-clinic testing to subject discontinuation, which included the exposure to both the OL and CL in-clinic testing. The extent of exposure for all subjects was within 1 day.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intent-to-treat (ITT)	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39094810Will A, Fishman M, Schultz D, Danko M, Verill D, Davies C, Retterath P, Miller N, Tonder L, Johanek L, Dinsmoor D, Tan Y, Franke A, Soghomonyan S. Improvements in Therapy Experience With Evoked Compound Action Potential Controlled, Closed-Loop Spinal Cord Stimulation-Primary Outcome of the ECHO-MAC Randomized Clinical Trial. J Pain. 2024 Nov;25(11):104646. doi: 10.1016/j.jpain.2024.104646. Epub 2024 Jul 31.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS) in people with Chronic Pain, run by MedtronicNeuro at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Proportion of Subjects With a Reduction in Overstimulation Sensation With SCS Using a Closed-loop Algorithm Compared With SCS in Open-loop (time frame: In-clinic testing (1 day)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04765735, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.