Chronic PainEVOKENCT02924129

Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation

A study testing Evoke Spinal Cord Stimulator (SCS) System in people with Chronic Pain and Back Pain, run by Saluda Medical Americas, Inc. at 16 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 the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Chronic Pain, Back Pain, Pain
What is being tested?: Evoke Spinal Cord Stimulator (SCS) System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 134 participants
Where: 16 sitesUnited States
Study dates: 27 Jan 2017to 9 Sep 2022
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 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is male or female between the ages of 18 and 80 years.
Have been diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.
Be an appropriate candidate for an SCS trial and the surgical procedures required in this study based on the clinical judgment of the Investigator.
Be willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.

Who cannot join

Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator.
Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.
Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).
Have prior experience with SCS.
Have an active systemic infection or local infection in the area of the surgical site.
Be pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal).
Be concomitantly participating in another clinical study.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Center for Pain Relief
Charleston, West Virginia, 25301
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Integrated Pain Solutions
Columbus, Ohio, 43240
Delaware Valley Pain & Spine Institute
Feasterville-Trevose, Pennsylvania, 19053
Advanced Pain Management
Greenfield, Wisconsin, 53221
Pain Management Associates
Lee's Summit, Missouri, 64086
Ainsworth Institute of Pain Management
New York, New York, 10022
Hope Research Institute
Phoenix, Arizona, 85027
Summit Pain Alliance
Santa Rosa, California, 95401
Thrive Clinic
Santa Rosa, California, 95403
Arizona Pain Specialists
Scottsdale, Arizona, 85258
Premier Pain Centers
Shrewsbury, New Jersey, 07702
IPM Medical Group
Walnut Creek, California, 94598
Center for Clinical Research
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Randomized Double-blind Study Examining the Safety and Efficacy of Using the Evoke™ Spinal Cord Stimulator (SCS) System With Feedback to Treat Patients With Chronic Pain of the Trunk and/or Limbs.

The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.

Conditions: Chronic Pain, Back Pain, Pain
Being tested: Evoke Spinal Cord Stimulator (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 Stimulator (SCS) SystemDevice
Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).

Study groups in NCT02924129
Study group	Role	What they receive
Evoke SCS with Feedback	Experimental	closed-loop/automatic stimulation Receives: Device: Evoke Spinal Cord Stimulator (SCS) System
Evoke SCS with Conventional	Active comparator	open-loop/manual stimulation Receives: Device: Evoke Spinal Cord Stimulator (SCS) System

What is being measured

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

Number of Participants With Composite Endpoint Success
The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Measured: 3 months

Secondary outcomes (9)

Percent Change From Baseline in Leg Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Measured: 3 months
Percent Change From Baseline in Back Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Measured: 3 months
Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Measured: 3 months
Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Measured: 3 months
Number of Participants With Composite Endpoint Success
The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.
Measured: 12 months
Percent Change From Baseline in Leg Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Measured: 12 months
Percent Change From Baseline in Back Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Measured: 12 months
Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Measured: 12 months
Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score
VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain
Measured: 12 months

Timeline

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

27 Jan 20179 Sep 2022

First posted5 Oct 2016 (estimated)
Study start27 Jan 2017
Primary completion21 Jun 2018
Study completion9 Sep 2022

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 (5)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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02924129
Sponsor's protocol ID: SCLSH1503
Acronym: EVOKE
Status last verified: Dec 2023
First submitted: 30 Sep 2016
Last updated: 3 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Mekhail NA, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Pope JE, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, McJunkin T, Carlson J, Kim CK, Yang MI, Stauss T, Petersen EA, Hagedorn JM, Rauck R, Kallewaard JW, Baranidharan G, Taylor RS, Poree L, Brounstein D, Duarte RV, Gmel GE, Gorman R, Gould I, Hanson E, Karantonis DM, Khurram A, Leitner A, Mugan D, Obradovic M, Ouyang Z, Parker J, Single P, Soliday N; EVOKE Study Group. ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesth Pain Med. 2024 May 7;49(5):346-354. doi: 10.1136/rapm-2023-104751.
PubMed 37640452
Kapural L, Mekhail NA, Costandi S, Gilmore C, Pope JE, Li S, Hunter CW, Poree L, Staats PS, Taylor RS, Eldabe S, Kallewaard JW, Thomson S, Petersen EA, Sayed D, Deer TR, Antony A, Budwany R, Leitner A, Soliday N, Duarte RV, Levy RM. Durable multimodal and holistic response for physiologic closed-loop spinal cord stimulation supported by objective evidence from the EVOKE double-blind randomized controlled trial. Reg Anesth Pain Med. 2024 Apr 2;49(4):233-240. doi: 10.1136/rapm-2023-104639.
PubMed 37491149
Costandi S, Kapural L, Mekhail NA, Jotwani R, Bertisch SM, Li S, Petersen E, Abejon D, Poree L, Ouyang Z, Venkatesan L, Mekhail MN, Gilligan CJ. Impact of Long-Term Evoked Compound Action Potential Controlled Closed-Loop Spinal Cord Stimulation on Sleep Quality in Patients With Chronic Pain: An EVOKE Randomized Controlled Trial Study Subanalysis. Neuromodulation. 2023 Jul;26(5):1030-1038. doi: 10.1016/j.neurom.2022.10.050. Epub 2022 Nov 25.
PubMed 36437161
Falowski SM, Kim CH, Obradovic M, Parker JL. A Prospective Multicenter Case Series Utilizing Intraoperative Neuromonitoring With Evoked Compound Action Potentials to Confirm Spinal Cord Stimulation Lead Placement. Neuromodulation. 2022 Jul;25(5):724-730. doi: 10.1016/j.neurom.2021.11.014. Epub 2022 Jan 26.
PubMed 35088735
Mekhail N, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Pope JE, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, Carlson J, Kim CK, Yang MI, Stauss T, Poree L; Evoke Study Group. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. Lancet Neurol. 2020 Feb;19(2):123-134. doi: 10.1016/S1474-4422(19)30414-4. Epub 2019 Dec 20.
PubMed 31870766

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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Randomized Double-blind Study Examining the Safety and Efficacy of Using the Evoke™ Spinal Cord Stimulator (SCS) System With Feedback to Treat Patients With Chronic Pain of the Trunk and/or Limbs.
ClinicalTrials.gov ID: NCT02924129
Acronym / sponsor ID: EVOKE / SCLSH1503
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: 134 participants (actual)
Lead sponsor: Saluda Medical Americas, Inc.Industry (pharma, biotech, devices)
Study start: 27 Jan 2017 (actual)
Primary completion: 21 Jun 2018 (actual)
Study completion: 9 Sep 2022 (actual)
First posted: 5 Oct 2016 (estimated)
Results: Posted 25 May 2021

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 the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Evoke SCS with Feedback	Experimental	Device: Evoke Spinal Cord Stimulator (SCS) Systemclosed-loop/automatic stimulation
Evoke SCS with Conventional	Active comparator	Device: Evoke Spinal Cord Stimulator (SCS) Systemopen-loop/manual stimulation

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Subject is male or female between the ages of 18 and 80 years.
Have been diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.
Be an appropriate candidate for an SCS trial and the surgical procedures required in this study based on the clinical judgment of the Investigator.
Be willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.

Key exclusion criteria (7 listed)

Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator.
Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.
Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).
Have prior experience with SCS.
Have an active systemic infection or local infection in the area of the surgical site.

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 Stimulator (SCS) SystemSpinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).	Device	Evoke SCS with Conventional, Evoke SCS with Feedback

Primary outcome

Number of Participants With Composite Endpoint Success
Time frame: 3 months
The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.

9 secondary outcomes

Percent Change From Baseline in Leg Pain VAS Score
Time frame: 3 months
Percent Change From Baseline in Back Pain VAS Score
Time frame: 3 months
Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score
Time frame: 3 months
Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score
Time frame: 3 months
Number of Participants With Composite Endpoint Success
Time frame: 12 months
Percent Change From Baseline in Leg Pain VAS Score
Time frame: 12 months
Percent Change From Baseline in Back Pain VAS Score
Time frame: 12 months
Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score
Time frame: 12 months
Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score
Time frame: 12 months

Results and safety

Results posted to the registry on 25 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Evoke SCS With Feedback	67	62
Evoke SCS With Conventional	67	63

Primary outcome: Number of Participants With Composite Endpoint Success

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Evoke SCS With Feedback n = 62	Evoke SCS With Conventional n = 63
Value	51	38

Evoke SCS With Feedback vs Evoke SCS With Conventional: p <0.001, normal approximation to the binomial

Population analysed: Intention-to-Treat (ITT), which included randomized patients with either known endpoint status or classified as a presumed non-responder (i.e., \<50% reduction in overall pain at trial or withdrew due to a device- or stimulation-related adverse event), and therefore imputed as a failure.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through primary completion (3-months post-implant).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Evoke SCS With Feedback	7 of 67 (10.4%)	14 of 67 (20.9%)	0 of 67
Evoke SCS With Conventional	4 of 67 (6%)	15 of 67 (22.4%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37640452Mekhail NA, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Pope JE, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, McJunkin T, Carlson J, Kim CK, Yang MI, Stauss T, Petersen EA, Hagedorn JM, Rauck R, Kallewaard JW, Baranidharan G, Taylor RS, Poree L, Brounstein D, Duarte RV, Gmel GE, Gorman R, Gould I, Hanson E, Karantonis DM, Khurram A, Leitner A, Mugan D, Obradovic M, Ouyang Z, Parker J, Single P, Soliday N; EVOKE Study Group. ECAP-controlled closed-loop versus open-loop SCS for the treatment of chronic pain: 36-month results of the EVOKE blinded randomized clinical trial. Reg Anesth Pain Med. 2024 May 7;49(5):346-354. doi: 10.1136/rapm-2023-104751.
Derived from this study: PubMed 37491149Kapural L, Mekhail NA, Costandi S, Gilmore C, Pope JE, Li S, Hunter CW, Poree L, Staats PS, Taylor RS, Eldabe S, Kallewaard JW, Thomson S, Petersen EA, Sayed D, Deer TR, Antony A, Budwany R, Leitner A, Soliday N, Duarte RV, Levy RM. Durable multimodal and holistic response for physiologic closed-loop spinal cord stimulation supported by objective evidence from the EVOKE double-blind randomized controlled trial. Reg Anesth Pain Med. 2024 Apr 2;49(4):233-240. doi: 10.1136/rapm-2023-104639.
Derived from this study: PubMed 36437161Costandi S, Kapural L, Mekhail NA, Jotwani R, Bertisch SM, Li S, Petersen E, Abejon D, Poree L, Ouyang Z, Venkatesan L, Mekhail MN, Gilligan CJ. Impact of Long-Term Evoked Compound Action Potential Controlled Closed-Loop Spinal Cord Stimulation on Sleep Quality in Patients With Chronic Pain: An EVOKE Randomized Controlled Trial Study Subanalysis. Neuromodulation. 2023 Jul;26(5):1030-1038. doi: 10.1016/j.neurom.2022.10.050. Epub 2022 Nov 25.
Derived from this study: PubMed 35088735Falowski SM, Kim CH, Obradovic M, Parker JL. A Prospective Multicenter Case Series Utilizing Intraoperative Neuromonitoring With Evoked Compound Action Potentials to Confirm Spinal Cord Stimulation Lead Placement. Neuromodulation. 2022 Jul;25(5):724-730. doi: 10.1016/j.neurom.2021.11.014. Epub 2022 Jan 26.
Derived from this study: PubMed 31870766Mekhail N, Levy RM, Deer TR, Kapural L, Li S, Amirdelfan K, Hunter CW, Rosen SM, Costandi SJ, Falowski SM, Burgher AH, Pope JE, Gilmore CA, Qureshi FA, Staats PS, Scowcroft J, Carlson J, Kim CK, Yang MI, Stauss T, Poree L; Evoke Study Group. Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial. Lancet Neurol. 2020 Feb;19(2):123-134. doi: 10.1016/S1474-4422(19)30414-4. Epub 2019 Dec 20.
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.

Dan Brounstein, MBA study director

Saluda Medical Americas, Inc.

16 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 Stimulator (SCS) System in people with Chronic Pain and Back Pain, run by Saluda Medical Americas, Inc. at 16 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 4 inclusion and 7 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 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 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 25 May 2021). 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?

Number of Participants With Composite Endpoint Success (time frame: 3 months). 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 NCT02924129, which also lists 5 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 3 Jan 2024.