Chronic PainNCT07267715
EVA: Evaluation of EVOKE Therapy Metrics Generated Using the Evoke System With EVA
An observational study of Chronic Pain, run by Dustin Reynolds, MD at 1 site in United States.
Trial summary
The Evoke Spinal Cord Stimulator (SCS) System (Evoke® System) is an FDA-approved device that is used to manage long lasting, severe pain that is not relieved by typical medical treatments. 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?
- Spinal Cord Stimulation (SCS) System
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2025to 1 Nov 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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
Study population: Subjects with chronic, intractable focal pain of the trunk and/or limbs will be screened for participation in this study. Subjects who provide informed consent and meet the eligibility criteria will be enrolled and will undergo a trial procedure. Following the trial phase subjects may receive a permanent implant. Enrollment will continue until 30 subjects receive a permanent implant. We estimate that up to 40 subjects will be enrolled in this registry.
Who may be able to join
- Subject is not pregnant and 18 years of age or older at the time of enrollment.
- Subject has a minimum NRS score of 6 or higher (where 10 indicates the worst imaginable pain) in primary area of pain at baseline.
- 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.
- Subject is willing to program the Evoke® System using EVA™ under the supervision of the study investigator or Qualified Health Professional.
- Subject is being trialed with a neurostimulation system for the first time.
- Subject is able to read and understand English.
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- Subject is capable of subjective evaluation; subject must be able to describe and rate his/her pain levels.
- Subject is willing and capable of giving informed consent.
- Subject is willing and able to comply with study-related requirements, procedures, and visits.
- Subject has adequate cognitive ability to use a patient programmer and recharger as determined by the Investigator.
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mount Carmel Health System
Columbus, Ohio, 43054
Cameron Rink, PhD, MBA, 614-546-4518, cameron.rink@mchs.com
Dustin Reynolds, MD
About this study
The Evoke Spinal Cord Stimulator (SCS) System (Evoke® System) is an FDA-approved device that is used to manage long lasting, severe pain that is not relieved by typical medical treatments.
This research registry is being conducted to collect data from patients treated with a SCS device in order to determine how the device impacts their chronic pain condition.
Read more
Specifically, the study aims to:
- Evaluate data collected from the SCS system on how well the system is working.
- Evaluate the feasibility of programming the SCS system independently without external assistance.
- Evaluate changes in physical function, fatigue, pain interference, mood, sleep, daily activities, pain control, and overall satisfaction with the device.
- Conditions
- Chronic Pain
- Being tested
- Spinal Cord Stimulation (SCS) System
- Keywords
- Treatment of chronic pain of the trunk and/or limbs.
- 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 Stimulation (SCS) SystemDevice
Spinal cord stimulation system as an aid in the management of chronic intractable pain of the trunk and/or limbs; and will be used within its commercially approved indication.
| Study group | Role | What they receive |
|---|---|---|
| SCS Evoke System Implant | Subjects with chronic, intractable focal pain of the trunk and/or limbs who undergo Evoke System implant. Receives: Device: Spinal Cord Stimulation (SCS) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evoke® therapy neural panel metrics generated by EVA™
The core neural panel metric generated by the Saluda Medical Evoke® therapy system, specifically via its EVA™ sensing technology, is the Evoked Compound Action Potential (ECAP). ECAPs are objective neurophysiological biomarkers that represent the spinal cord's electrical response to stimulation.
Measured: At time of EVA programming and through study completion (up to 30 days)
Secondary outcomes (3)
Pain Locus of Control
The PLOC classifies the location in which individuals realize predominantly who or what stops the control of their pain. Factor analysis of the main components of this new scale revealed four dimensions: internal LC, chance LC, other people LC (friends and family), doctor and health professional LC. PLOC will be measured using an adapted version of a general purpose, condition-specific Multidimensional Health Locus of Control (MHLC) scale. The responses will be shortened from 6-level to 4-level: strongly agree, agree, disagree and strongly disagree. Each subscale receives an independent score, ranging from 6 to 24 (internal and chance LC subscales) and from 3 to 12 (health professionals and others LC subscales).
Measured: Up to 30 days
Numeric Rating Scale
The NRS is a subjective measure of pain. It is a commonly used pain assessment tool where individuals rate their pain on a scale of 0 to 10, with 0 representing no pain and 10 representing the worst possible pain. It's a simple, quick, and widely accepted method for quantifying pain intensity.
Measured: Up to 30 days
PROMIS-29+2
The PROMIS-29+2 consists of the PROMIS-29 profile (v2.1) and two 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: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start30 Nov 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Dustin Reynolds, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Saluda Medical Pty Ltd
- Responsible party
- Sponsor-investigator, Dustin Reynolds, MD, Mount Carmel Health System
- Investigators
- Dustin Reynolds, MD, Principal investigator, Mount Carmel Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267715
- Sponsor's protocol ID
- 250714-1
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVA: Evaluation of EVOKE Therapy Metrics Generated Using the Evoke System With EVA
- ClinicalTrials.gov ID
- NCT07267715
- Acronym / sponsor ID
- 250714-1
- Conditions
- Chronic Pain
- Keywords
- Treatment of chronic pain of the trunk and/or limbs.
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dustin Reynolds, MDUniversity, hospital or other
- Collaborators
- Saluda Medical Pty Ltd
- Study start
- 30 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 5 Dec 2025 (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 Evoke Spinal Cord Stimulator (SCS) System (Evoke® System) is an FDA-approved device that is used to manage long lasting, severe pain that is not relieved by typical medical treatments.
This research registry is being conducted to collect data from patients treated with a SCS device in order to determine how the device impacts their chronic pain condition.
Specifically, the study aims to:
- Evaluate data collected from the SCS system on how well the system is working.
- Evaluate the feasibility of programming the SCS system independently without external assistance.
- Evaluate changes in physical function, fatigue, pain interference, mood, sleep, daily activities, pain control, and overall satisfaction with the device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCS Evoke System Implant | – | Device: Spinal Cord Stimulation (SCS) SystemSubjects with chronic, intractable focal pain of the trunk and/or limbs who undergo Evoke System implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with chronic, intractable focal pain of the trunk and/or limbs will be screened for participation in this study. Subjects who provide informed consent and meet the eligibility criteria will be enrolled and will undergo a trial procedure. Following the trial phase subjects may receive a permanent implant. Enrollment will continue until 30 subjects receive a permanent implant. We estimate that up to 40 subjects will be enrolled in this registry.
Key inclusion criteria (10 listed)
- Subject is not pregnant and 18 years of age or older at the time of enrollment.
- Subject has a minimum NRS score of 6 or higher (where 10 indicates the worst imaginable pain) in primary area of pain at baseline.
- 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.
- Subject is willing to program the Evoke® System using EVA™ under the supervision of the study investigator or Qualified Health Professional.
- Subject is being trialed with a neurostimulation system for the first time.
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
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 Stimulation (SCS) SystemSpinal cord stimulation system as an aid in the management of chronic intractable pain of the trunk and/or limbs; and will be used within its commercially approved indication. | Device | SCS Evoke System Implant |
Primary outcome
Evoke® therapy neural panel metrics generated by EVA™
Time frame: At time of EVA programming and through study completion (up to 30 days)
The core neural panel metric generated by the Saluda Medical Evoke® therapy system, specifically via its EVA™ sensing technology, is the Evoked Compound Action Potential (ECAP). ECAPs are objective neurophysiological biomarkers that represent the spinal cord's electrical response to stimulation.
3 secondary outcomes
Pain Locus of Control
Time frame: Up to 30 days
Numeric Rating Scale
Time frame: Up to 30 days
PROMIS-29+2
Time frame: Up to 30 days
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 5 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Dustin Reynolds, MD principal investigator
Mount Carmel Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Dustin Reynolds, MD at 1 site 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 10 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: opening soon, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Melissa B. Showe (1-614-775-6607, melissa.showe@mchs.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evoke® therapy neural panel metrics generated by EVA™ (time frame: At time of EVA programming and through study completion (up to 30 days)). 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 5 Dec 2025.