Chronic PainECHO-MDTNCT06499220
Electrically Evoked Compound Action Potentials Human Observation Medtronic System Study (ECHO-MDT)
A study testing Spinal Cord Stimulator in people with Chronic Pain, run by MedtronicNeuro at 10 sites in United States.
Trial summary
This is a prospective, multi-center, non-significant risk IDE study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system. comprised of Medtronic hardware or off the shelf hardware, which uses recorded waveforms to adjust stimulation amplitude. 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?
- Spinal Cord Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 10 sitesUnited States
- Study dates
- 30 Oct 2019to 16 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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*
- 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 *Candidate for or undergoing 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.
Who cannot join
- Implanted electrical cardiac device (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)
- Currently diagnosed with a disease that may confound ability to evoke compound action potentials, e.g. multiple sclerosis, as determined by the investigator
- 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")
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Coastal Pain and Spinal Diagnostics
Carlsbad, California, 92009
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
MercyOne Des Moines Medical Center
Des Moines, Iowa, 50314
Nura Research Institute
Edina, Minnesota, 55435
Twin Cities Pain Clinic
Edina, Minnesota, 55439
Kettering Health
Kettering, Ohio, 45429
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, 17601
iSpine Pain Physicians
Maple Grove, Minnesota, 55369
Rockefeller Neuroscience Institute West Virginia University
Morgantown, West Virginia, 26505
Premier Pain Treatment Institute
Mount Orab, Ohio, 45154
About this study
This is a prospective, multi-center, non-significant risk IDE study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system. comprised of Medtronic hardware or off the shelf hardware, which uses recorded waveforms to adjust stimulation amplitude.
- Conditions
- Chronic Pain
- Being tested
- Spinal Cord Stimulator
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord StimulatorDevice
Spinal Cord Stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs.
| Study group | Role | What they receive |
|---|---|---|
| ECAP Recording | Experimental | Not described Receives: Device: Spinal Cord Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of ECAP data (sensing configurations, stimulation parameters eliciting ECAPs, control policies/algorithms for recording ECAPs) via the research system.
The ECAP data collected is prototype system/device information for development of a closed loop system.
Measured: 1 hour to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start30 Oct 2019
- Primary completion16 Oct 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499220
- Sponsor's protocol ID
- MDT19014
- Acronym
- ECHO-MDT
- Status last verified
- Jul 2024
- First submitted
- 18 Jun 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrically Evoked Compound Action Potentials Human Observation Medtronic System Study (ECHO-MDT)
- ClinicalTrials.gov ID
- NCT06499220
- Acronym / sponsor ID
- ECHO-MDT / MDT19014
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center, non-significant risk IDE study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system. comprised of Medtronic hardware or off the shelf hardware, which uses recorded waveforms to adjust stimulation amplitude.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECAP Recording | Experimental | Device: Spinal Cord Stimulator |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 22 years of age or older
- Candidate for or undergoing Medtronic SCS device trial for labeled indication*
- 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 *Candidate for or undergoing 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.
Key exclusion criteria (6 listed)
- Implanted electrical cardiac device (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)
- Currently diagnosed with a disease that may confound ability to evoke compound action potentials, e.g. multiple sclerosis, as determined by the investigator
- 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
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 |
|---|---|---|
| Spinal Cord StimulatorSpinal Cord Stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs. | Device | ECAP Recording |
Primary outcome
Collection of ECAP data (sensing configurations, stimulation parameters eliciting ECAPs, control policies/algorithms for recording ECAPs) via the research system.
Time frame: 1 hour to 72 hours
The ECAP data collected is prototype system/device information for development of a closed loop system.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
Related trials for Chronic Pain
Recruiting
Dry Needling in Multiple Sclerosis
Multiple Sclerosis
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Recruiting
VR and Cooled Genicular Nerve Radio Frequency Ablation for Chronic Knee Pain
Pain, Chronic
Recruiting
Evaluation of Cognitive Behavioral Therapy for Long-term Pain in Rheumatic Disease, Including Validation of AE-FS
Rheumatic Diseases, Pain, Chronic
Active, not recruiting
Cervical Stabilization vs Scapular Clock Exercises for Chronic Non-Specific Neck Pain
Chronic Non-Specific Neck Pain
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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Cord Stimulator in people with Chronic Pain, run by MedtronicNeuro at 10 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 5 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 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Collection of ECAP data (sensing configurations, stimulation parameters eliciting ECAPs, control policies/algorithms for recording ECAPs) via the research system. (time frame: 1 hour to 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2024.