Chronic PainNeural PanelNCT06229470
Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop SCS to Guide Treatment of Chronic Pain
A study testing Evoke Spinal Cord Stimulation (SCS) System in people with Chronic Pain, run by Saluda Medical Pty Ltd at 25 sites in United States.
Trial summary
The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic 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
- 250 participants
- Where
- 25 sitesUnited States
- Study dates
- 8 Mar 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 is planning to have a temporary trial with the Evoke System to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and/or intractable low back pain and leg pain.
- Leg pain score ≥ 6 cm (Visual Analog Scale [VAS]).
- Back pain score ≥ 6 cm (VAS).
- Subject is able to speak, read, and/or understand English, willing and capable of giving informed consent, and able to comply with study-related requirements, procedures, and visits.
- Subject is not pregnant and not <18 years of age.
Who cannot join
- N/A
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Michigan Pain Specialists
Ann Arbor, Michigan, 48108
Spanish Hills Interventional Pain Specialists
Camarillo, California, 93010
Goodman Campbell Brain and Spine
Carmel, Indiana, 46032
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Garden State Pain and Orthopedics
Clifton, New Jersey, 07013
Institute of Precision Pain Medicine
Corpus Christi, Texas, 78414
Pohlman Pain Associates
Delray Beach, Florida, 33445
Metro Anesthesia & Pain Management
Des Moines, Iowa, 50317
Spine and Joint Institute
Glen Burnie, Maryland, 21061
Tricity Research Center, LLC
Grand Island, Nebraska, 68803
Carolinas Center for Advanced Management of Pain
Greenville, South Carolina, 29615
DBPS Research
Greenwood Village, Colorado, 80111
Advanced Pain Institute
Hammond, Louisiana, 70403
Horizon Clinical Research
Jasper, Georgia, 30143
Pain Consultants of San Diego
La Mesa, California, 91942
Lakeside Spine and Pain
Lake Havasu City, Arizona, 86403
Restorative Pain Institute
Louisville, Kentucky, 40241
Premier Pain Treatment Institute
Loveland, Ohio, 45140
Reno Tahoe Pain Associates
Reno, Nevada, 89509
Pain Clinic of Michigan
Rochester Hills, Michigan, 48309
Rockford Pain Center
Rockford, Illinois, 61107
Pacific Research Institute
Santa Rosa, California, 94104
Victoria Pain and Rehabilitation Center
Victoria, Texas, 77904
Boomerang Healthcare
Walnut Creek, California, 94598
Seaside Clinical Research Institute
Wilmington, North Carolina, 28412
About this study
Official title: A Prospective, Multicenter, Single-arm Study Evaluating the Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop Spinal Cord Stimulation (SCS) to Guide Treatment of Patients With Chronic Pain of the Trunk and/or Limbs.
The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.
- Conditions
- Chronic Pain
- Being tested
- Evoke Spinal Cord Stimulation (SCS) System
- Medical subject headings
- Chronic Pain
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 (SCS) system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude.
| 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.
Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
physiological parameter to be measured = Evoked Compound Action Potentials (ECAPs); measurement tool = Evoke SCS System
Measured: through 6-months post-implant
Secondary outcomes (3)
Change in Visual Analogue Scale (VAS) Pain
Visual Analogue Scale (VAS) to rate pain intensity (0mm [no pain] to 100mm [worst pain imaginable])
Measured: through 6-months post-implant
Change in PROMIS-29+2
PROMIS-29 Profile and 2 PROMIS Cognitive Function Abilities items. The PROMIS-29 is a 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.
Measured: through 6-months post-implant
Change in PROMIS-10 Global Health
10-item instrument that assesses Physical Health and Mental Health
Measured: through 6-months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start8 Mar 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saluda Medical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229470
- Sponsor's protocol ID
- D103977
- Acronym
- Neural Panel
- Status last verified
- May 2026
- First submitted
- 11 Jan 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Single-arm Study Evaluating the Clinical Utility of Neurophysiological Measurements of ECAP-controlled Closed-loop Spinal Cord Stimulation (SCS) to Guide Treatment of Patients With Chronic Pain of the Trunk and/or Limbs.
- ClinicalTrials.gov ID
- NCT06229470
- Acronym / sponsor ID
- Neural Panel / D103977
- Conditions
- Chronic Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Saluda Medical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 29 Jan 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.
The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.
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 (5 listed)
- Subject is planning to have a temporary trial with the Evoke System to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome and/or intractable low back pain and leg pain.
- Leg pain score ≥ 6 cm (Visual Analog Scale [VAS]).
- Back pain score ≥ 6 cm (VAS).
- Subject is able to speak, read, and/or understand English, willing and capable of giving informed consent, and able to comply with study-related requirements, procedures, and visits.
- Subject is not pregnant and not <18 years of age.
Key exclusion criteria (1 listed)
- N/A
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 (SCS) 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
Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
Time frame: through 6-months post-implant
physiological parameter to be measured = Evoked Compound Action Potentials (ECAPs); measurement tool = Evoke SCS System
3 secondary outcomes
Change in Visual Analogue Scale (VAS) Pain
Time frame: through 6-months post-implant
Change in PROMIS-29+2
Time frame: through 6-months post-implant
Change in PROMIS-10 Global Health
Time frame: through 6-months post-implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- 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.
25 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, run by Saluda Medical Pty Ltd at 25 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 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Evoked Compound Action Potentials (ECAPs) as measured by the Evoke SCS System (time frame: through 6-months post-implant). 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 27 Aug 2026.