ClinicalTrials.gg
Sign In
CompletedNCT04319887ECAPUpdated Dec 31, 2024Results posted

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

An interventional study of Evoke Spinal Cord Stimulation (SCS) System in Chronic Pain, Back Pain and Pain, sponsored by Saluda Medical Pty Ltd. Completed at 22 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-31.

Sponsored by Saluda Medical Pty Ltd · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Pain
  • Back Pain
  • Pain

Keywords

  • Chronic Pain
  • Back Pain
  • Leg Pain
  • Pain
  • Neurologic Manifestations
  • Nervous System Diseases
  • Signs and Symptoms
  • SCS
  • Closed Loop
03

In context

Chronic Pain

2,998 studies on the registry are indexed under Chronic Pain; 706 are open to participants now.

This study's enrollment of 300 is above the median of 60 across 2,209 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Saluda Medical Pty Ltd is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    ECAP-controlled, closed-loop SCS

    Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

    Device: Evoke Spinal Cord Stimulation (SCS) System

Interventions

  • DeviceEvoke Spinal Cord Stimulation (SCS) System

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12-months post-implant

Other outcomes

  1. Change in Pain

    Visual Analogue Scale (VAS) to rate pain intensity

    Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

  2. Change in PROMIS-29

    29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity.

    Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

  3. Change in PROMIS-10 Global

    10-item instrument that assesses Physical Health and Mental Health

    Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

  4. Change in Profile of Mood States (POMS 2-A Short)

    35-item instrument that assesses mood states overall (Total Mood Disturbance) and six mood clusters: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. A scale score is also calculated for Friendliness.

    Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

  5. Rate of Patient Global Impression of Change (PGIC)

    Single item measure of global improvement with treatment

    Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

  6. Rate of Patient Satisfaction With Therapy

    Single item measure of satisfaction with treatment

    Time frame: end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

07

Results

Posted Dec 31, 2024

Participant flow

Participant flow — Overall Study
MilestoneECAP-controlled, Closed-loop SCS
Started231
Completed208
Not completed23

Outcome measures

PrimaryEvoked 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.

Time frame:
12-months post-implant
Reported as:
Median · ratio
Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System
ratioECAP-controlled, Closed-loop SCS
Evoked Compound Action Potentials (ECAPs) as Measured by the Evoke SCS System1.3 (1.1 to 1.5)
Statistical analysis
  • ECAP-controlled, Closed-loop SCS ·
Other pre-specifiedChange in Pain

Visual Analogue Scale (VAS) to rate pain intensity

Time frame:
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

Results for this outcome have not been posted.

Other pre-specifiedChange in PROMIS-29

29-item profile instrument that assesses 8 universal domains (not disease-specific): Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity.

Time frame:
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

Results for this outcome have not been posted.

Other pre-specifiedChange in PROMIS-10 Global

10-item instrument that assesses Physical Health and Mental Health

Time frame:
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

Results for this outcome have not been posted.

Other pre-specifiedChange in Profile of Mood States (POMS 2-A Short)

35-item instrument that assesses mood states overall (Total Mood Disturbance) and six mood clusters: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. A scale score is also calculated for Friendliness.

Time frame:
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

Results for this outcome have not been posted.

Other pre-specifiedRate of Patient Global Impression of Change (PGIC)

Single item measure of global improvement with treatment

Time frame:
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

Results for this outcome have not been posted.

Other pre-specifiedRate of Patient Satisfaction With Therapy

Single item measure of satisfaction with treatment

Time frame:
end of trial period; 1-, 3-, 6-, 12-, 18-, and 24-months post-implant

Results for this outcome have not been posted.

Adverse events

Collected over AE data were collected from consent through study completion/exit, an average of 1 year.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
ECAP-controlled, Closed-loop SCS3/300 (1%)38/300 (12.7%)59/300 (19.7%)
Most frequent serious events
Showing 10 of 34
Most frequent serious events
EventECAP-controlled, Closed-loop SCS
Fall or Trip or Slip or TwistInjury, poisoning and procedural complications5/300
PneumoniaRespiratory, thoracic and mediastinal disorders3/300
Urinary Tract InfectionRenal and urinary disorders3/300
Cholelithiasis or GallstonesHepatobiliary disorders2/300
Dural Puncture or TearNervous system disorders2/300
Nerve Root or Spinal Cord InjuryNervous system disorders2/300
OverdosePsychiatric disorders2/300
SepticemiaInfections and infestations2/300
Abdominal PainGastrointestinal disorders1/300
Activities of Daily Living (ADL) InjuryInjury, poisoning and procedural complications1/300
Most frequent other events
Most frequent other events
EventECAP-controlled, Closed-loop SCS
Fall or Trip or Slip or TwistInjury, poisoning and procedural complications37/300
Upper Respiratory Symptoms or Upper Respiratory Tract InfectionRespiratory, thoracic and mediastinal disorders21/300
Activities of Daily Living (ADL) InjuryInjury, poisoning and procedural complications16/300
ArthritisMusculoskeletal and connective tissue disorders15/300

Baseline characteristics

Age, Continuous
Age, Continuous(years)ECAP-controlled, Closed-loop SCS
Mean63.3 ± 12.5
Sex: Female, Male
Sex: Female, Male(Participants)ECAP-controlled, Closed-loop SCS
Female126
Male105
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)ECAP-controlled, Closed-loop SCS
Hispanic or Latino13
Not Hispanic or Latino218
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)ECAP-controlled, Closed-loop SCS
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American11
White217
More than one race2
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)ECAP-controlled, Closed-loop SCS
United States231
08

Study locations

22 sites
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
  • Coastal Pain and Spinal Diagnostics
    Carlsbad, California 92009, United States
  • Pacific Research Institute
    Santa Rosa, California 95403, United States
  • The Orthopaedic Institute, PA
    Gainesville, Florida 32607, United States
  • Alliance Spine and Pain Centers
    Atlanta, Georgia 30326, United States
  • Southern Pain and Spine
    Fayetteville, Georgia 30214, United States
  • Axis Spine Center
    Hayden Lake, Idaho 83835, United States
  • University of Kansas Medical Center Research Institute
    Kansas City, Kansas 66160, United States
  • Ochsner Clinic
    New Orleans, Louisiana 70121, United States
  • Interventional Spine and Pain Physicians
    Maple Grove, Minnesota 55369, United States
  • Nevada Advanced Pain Specialists
    Reno, Nevada 89511, United States
  • Albany Medical College
    Albany, New York 12208, United States
  • Duke University
    Durham, North Carolina 27705, United States
  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
  • Cleveland Clinic Foundation
    Cleveland, Ohio 44195, United States
  • Oregon Health and Science University
    Portland, Oregon 97239, United States
  • Spinal Diagnostics, PC
    Tualatin, Oregon 97062, United States
  • Delaware Valley Pain & Spine Institute
    Feasterville-Trevose, Pennsylvania 19053, United States
  • Center for Interventional Pain and Spine
    Lancaster, Pennsylvania 55419, United States
  • Sprintz Center for Pain PLLC
    Shenandoah, Texas 77384, United States
  • Precision Spine Care
    Tyler, Texas 75701, United States
  • St. Francis Hospital
    Charleston, West Virginia 25301, United States
09

References and documents

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 ↗

Study documents

  • Protocol and statistical analysis plan · May 27, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2020 to primary completion in Dec 2023, 37 months.

Results were first posted in Dec 2024, 1 year after primary completion.

Of 87 industry-sponsored interventional studies with no phase under Chronic Pain, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's 37 months is above that.

Counting every sponsor, half of 1,296 studies reached it within 21 months; a quarter within 9 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2020
First posted
Mar 24, 2020
StartActual
Oct 29, 2020
Primary completionActual
Dec 28, 2023
CompletionActual
Dec 28, 2023
Results first posted
Dec 31, 2024
Last update
Dec 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04319887
Lead sponsor
Saluda Medical Pty Ltd
Responsible party
Sponsor
First posted
Mar 24, 2020
Start date
Oct 29, 2020
Primary completion
Dec 28, 2023
Completion
Dec 28, 2023
Results posted
Dec 31, 2024
Last update
Dec 31, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Chronic Pain →

Other studies from this sponsor

Saluda Medical Pty Ltd

Start the discussion