Chronic PainECAPNCT04319887

ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)

A study testing Evoke Spinal Cord Stimulation (SCS) System in people with Chronic Pain and Back Pain, run by Saluda Medical Pty Ltd at 22 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

The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pain, Back Pain, Pain
What is being tested?: Evoke Spinal Cord Stimulation (SCS) System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 22 sitesUnited States
Study dates: 29 Oct 2020to 28 Dec 2023
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has chronic intractable pain of the trunk and/or limbs.
Subject is willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.

Who cannot join

Subject is unable to operate the system.
Subject is an unsuitable surgical candidate.
Subject has a condition currently requiring or likely to require the use of diathermy.
Subject has another implantable stimulator such as demand type pacemakers or cardioverter defibrillator.
Subject is <18 years old.
Subject is pregnant or nursing.
Subject is allergic, or has shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body.
Subject is being treated with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS).

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

Albany Medical College
Albany, New York, 12208
Alliance Spine and Pain Centers
Atlanta, Georgia, 30326
Coastal Pain and Spinal Diagnostics
Carlsbad, California, 92009
St. Francis Hospital
Charleston, West Virginia, 25301
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27705
Southern Pain and Spine
Fayetteville, Georgia, 30214
Delaware Valley Pain & Spine Institute
Feasterville-Trevose, Pennsylvania, 19053
The Orthopaedic Institute, PA
Gainesville, Florida, 32607
Axis Spine Center
Hayden Lake, Idaho, 83835
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, 55419
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Interventional Spine and Pain Physicians
Maple Grove, Minnesota, 55369
Ochsner Clinic
New Orleans, Louisiana, 70121
Oregon Health and Science University
Portland, Oregon, 97239
Nevada Advanced Pain Specialists
Reno, Nevada, 89511
Pacific Research Institute
Santa Rosa, California, 95403
Sprintz Center for Pain PLLC
Shenandoah, Texas, 77384
Spinal Diagnostics, PC
Tualatin, Oregon, 97062
Precision Spine Care
Tyler, Texas, 75701

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Single-arm Study Examining ECAP-controlled, Closed-loop Stimulation With the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.

Conditions: Chronic Pain, Back Pain, Pain
Being tested: Evoke Spinal Cord Stimulation (SCS) System
Keywords: Chronic Pain, Back Pain, Leg Pain, Pain, Neurologic Manifestations, Nervous System Diseases, Signs and Symptoms, SCS, Closed Loop
Medical subject headings: Chronic Pain, Back Pain, Pain, Neurologic Manifestations, Nervous System Diseases, Signs and Symptoms

What participants receive

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

Evoke Spinal Cord Stimulation (SCS) SystemDevice
A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Study groups in NCT04319887
Study group	Role	What they receive
ECAP-controlled, closed-loop SCS	Experimental	Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude Receives: Device: Evoke Spinal Cord Stimulation (SCS) System

What is being measured

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

Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System
Dose ratio is determined by the estimated current (mA) at the median ECAP level divided by the current (mA) at the ECAP threshold. The dose ratio allows for both the individualization of a patient's neural dose and comparison across patients, using their ECAP threshold and unique dose response. This metric normalizes for distance between the electrode and the spinal cord and the distances between the stimulation and recording electrodes. The dose ratio reflects the amount of dorsal column activation elicited by stimulation with respect to threshold levels. For example, if the dose is at ECAP threshold, this value will be 1. If the dose is 30% higher than ECAP threshold, this value will be 1.3.
Measured: 12-months post-implant

Timeline

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

29 Oct 202028 Dec 2023

First posted24 Mar 2020
Study start29 Oct 2020
Primary completion28 Dec 2023
Study completion28 Dec 2023

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 (2)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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04319887
Sponsor's protocol ID: CLIN-PCL-006732
Acronym: ECAP
Status last verified: Dec 2024
First submitted: 17 Mar 2020
Last updated: 31 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Pope JE, Vu CM, Goree JH, Cornidez EG, Trainor D, Khurram A, Gould I, Karantonis DM. Objective, Same-Day SCS Trials with ECAP-Controlled Closed-Loop Therapy: Depth of Response is Maintained from Trial to 12 months. Pain Ther. 2026 Apr;15(2):569-583. doi: 10.1007/s40122-026-00821-2. Epub 2026 Mar 3.
PubMed 41774424
Pope JE, Antony A, Petersen EA, Rosen SM, Sayed D, Hunter CW, Goree JH, Vu CM, Bhandal HS, Shumsky PM, Bromberg TA, Smith GL, Lam CM, Kalia H, Lee JM, Khurram A, Gould I, Karantonis DM, Deer TR. Identifying SCS Trial Responders Immediately After Postoperative Programming with ECAP Dose-Controlled Closed-Loop Therapy. Pain Ther. 2024 Oct;13(5):1173-1185. doi: 10.1007/s40122-024-00631-4. Epub 2024 Jul 9.
PubMed 38977651

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?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Single-arm Study Examining ECAP-controlled, Closed-loop Stimulation With the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs
ClinicalTrials.gov ID: NCT04319887
Acronym / sponsor ID: ECAP / CLIN-PCL-006732
Conditions: Chronic Pain, Back Pain, Pain
Keywords: Chronic Pain, Back Pain, Leg Pain, Pain, Neurologic Manifestations, Nervous System Diseases, Signs and Symptoms, SCS
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Saluda Medical Pty LtdIndustry (pharma, biotech, devices)
Study start: 29 Oct 2020 (actual)
Primary completion: 28 Dec 2023 (actual)
Study completion: 28 Dec 2023 (actual)
First posted: 24 Mar 2020 (actual)
Results: Posted 31 Dec 2024

Clinical summary

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

The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ECAP-controlled, closed-loop SCS	Experimental	Device: Evoke Spinal Cord Stimulation (SCS) SystemSpinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subject has chronic intractable pain of the trunk and/or limbs.
Subject is willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.

Key exclusion criteria (8 listed)

Subject is unable to operate the system.
Subject is an unsuitable surgical candidate.
Subject has a condition currently requiring or likely to require the use of diathermy.
Subject has another implantable stimulator such as demand type pacemakers or cardioverter defibrillator.
Subject is <18 years old.

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
Evoke Spinal Cord Stimulation (SCS) SystemA spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude	Device	ECAP-controlled, closed-loop SCS

Primary outcome

Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System
Time frame: 12-months post-implant
Dose ratio is determined by the estimated current (mA) at the median ECAP level divided by the current (mA) at the ECAP threshold. The dose ratio allows for both the individualization of a patient's neural dose and comparison across patients, using their ECAP threshold and unique dose response. This metric normalizes for distance between the electrode and the spinal cord and the distances between the stimulation and recording electrodes. The dose ratio reflects the amount of dorsal column activation elicited by stimulation with respect to threshold levels. For example, if the dose is at ECAP threshold, this value will be 1. If the dose is 30% higher than ECAP threshold, this value will be 1.3.

Results and safety

Results posted to the registry on 31 Dec 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
ECAP-controlled, Closed-loop SCS	231	208

Primary outcome: Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System

Time frame: 12-months post-implant. Median (Inter-Quartile Range). Unit: ratio

Measure	ECAP-controlled, Closed-loop SCS n = 208
Value	1.3 (1.1 to 1.5)

Population analysed: patients who completed the 12-month follow-up visit

Adverse events

Time frame: AE data were collected from consent through study completion/exit, an average of 1 year.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ECAP-controlled, Closed-loop SCS	38 of 300 (12.7%)	59 of 300 (19.7%)	3 of 300

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41774424Pope JE, Vu CM, Goree JH, Cornidez EG, Trainor D, Khurram A, Gould I, Karantonis DM. Objective, Same-Day SCS Trials with ECAP-Controlled Closed-Loop Therapy: Depth of Response is Maintained from Trial to 12 months. Pain Ther. 2026 Apr;15(2):569-583. doi: 10.1007/s40122-026-00821-2. Epub 2026 Mar 3.
Derived from this study: PubMed 38977651Pope JE, Antony A, Petersen EA, Rosen SM, Sayed D, Hunter CW, Goree JH, Vu CM, Bhandal HS, Shumsky PM, Bromberg TA, Smith GL, Lam CM, Kalia H, Lee JM, Khurram A, Gould I, Karantonis DM, Deer TR. Identifying SCS Trial Responders Immediately After Postoperative Programming with ECAP Dose-Controlled Closed-Loop Therapy. Pain Ther. 2024 Oct;13(5):1173-1185. doi: 10.1007/s40122-024-00631-4. Epub 2024 Jul 9.
Individual participant dataSharing planned: No

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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.

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

Questions about this trial

What is this clinical trial studying?

A study testing Evoke Spinal Cord Stimulation (SCS) System in people with Chronic Pain and Back Pain, run by Saluda Medical Pty Ltd at 22 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 2 inclusion and 8 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 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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 31 Dec 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?

Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System (time frame: 12-months post-implant). 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 NCT04319887, which also lists 2 linked publications.

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 31 Dec 2024.