Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001018303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
16/04/2026
Date registered
Help: Date registered
18/08/2026
Date last updated
Help: Date last updated
18/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
18/08/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Physiological Biomarker-Based Neural Dosing Study:
A prospective, multicenter, single-arm study evaluating the clinical utility of biomarker-based neural dosing using evoked compound action potential (ECAP)-controlled closed-loop spinal cord stimulation (SCS).
Scientific title
Physiological Biomarker-Based Neural Dosing Study:
A prospective, multicenter, single-arm study evaluating the clinical utility of biomarker-based neural dosing using evoked compound action potential (ECAP)-controlled closed-loop spinal cord stimulation (SCS) in those experiencing chronic intractable pain of the trunk and/or limbs.
Additional trial identifiers [1] 317061 0
Nil
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Chronic pain of the trunk and/or limbs 341579 0
Condition category
Condition code
Neurological 337648 337648 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The Evoke Spinal Cord Stimulator (SCS) System (Evoke System) is indicated 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.

With the development of ECAP CL-SCS, this is the first time in SCS that true scientific inquiry into the neural dose that produces the clinical effect is available. With the Evoke System, objective measurement of therapy delivery through ECAPs allows for the reproducibility of the neural dose delivered in addition to individualization based on a patient’s unique spinal cord measurements.

To understand the neurophysiological measurements (i.e., neural panel metrics) that correspond with the maximal analgesic effect (MAE) achieved with ECAP CL-SCS and provide guidelines for therapy delivery and adherence in future applications of CL-SCS, data from subjects with chronic back and leg pain (greater than or equal to 60mm on a Visual Analog Scale [VAS]) receiving CL-SCS in three studies of the Evoke System (Evoke randomized controlled trial [RCT] closed-loop arm [NCT02924129], ECAP [NCT04319887], and Durability [NCT04627974] were analyzed.

The neural panel metrics included the following:
System utilization: the proportion of time the system was on for the week prior to the visit.
Percent time above ECAP threshold: the proportion of time a patient received stimulation above their individual ECAP threshold, out of the total stimulation time.
ECAP dose: the median ECAP level (normalized ECAP amplitude [µV]).
Dose ratio: the estimated current (mA) at the median ECAP level divided by the current (mA) at the ECAP threshold. Patients will be programmed to a dose ratio of 1.4x ECAP threshold.

The spinal cord stimulator is implanted under the skin and is programmed by a device representative. The device representative delivers electrical impulses to the spinal cord and titrates the dose of stimulation up to a value of 40% above the point of neural activation. Patients are encouraged to run their stimulator at this precise dose. Patients are able to control their therapy with a remote control. Adherence will be monitored at each milestone visit.

The neural panel metric measurements are clinical tools to be used by healthcare professionals. Healthcare professionals exercise their own clinical judgment based on the information provided to make decisions about treatment. The device will be programmed in accordance with the patients needs per the commercially available instructions for use. Individual patient spinal cord measurements and the patient’s subjective feedback should be considered when providing recommendations and titrating/tapering for each patient.

The general guidelines for each individual patient’s therapy will be translated into the number of bars that should be illuminated for each applicable program on the patient’s remote control. This will be done to educate the patient on the therapy that produced the best clinical outcome in past patients when taking into account their own individual spinal cord measurements. The physician and patient will always have full control to modify treatment as needed for the individual’s therapy. The patient will always have full control of their system to turn on, off, or adjust their stimulation per the TGA approved labelling.

Patients will be followed up at trial end, and 3, 6 and 12 months post permanent implant.

Patients are encouraged to run their stimulator at the precise dose at all times, unless instructed by the technician (e.g. the patient only has pain during the daytime and will use the SCS during daytime hours). Patients will continue to use this precise dose of stimulation on their preferred program after the trial ends. The trial end refers to the end of the 12 month study duration.
Intervention code [1] 333820 0
Treatment: Devices
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345142 0
The primary outcome of the study is to measure change in pain intensity.
Timepoint [1] 345142 0
The primary timepoint is 12 months post-implant.
Secondary outcome [1] 460595 0
Quality of Life
Timepoint [1] 460595 0
12 months post-implant
Secondary outcome [2] 464087 0
Physical function
Timepoint [2] 464087 0
12 months post-implant
Secondary outcome [3] 464089 0
Pain self-efficacy
Timepoint [3] 464089 0
12 months post-implant
Secondary outcome [4] 464091 0
Depression, anxiety and stress
Timepoint [4] 464091 0
12 months post-implant
Secondary outcome [5] 465502 0
Programming parameters
Timepoint [5] 465502 0
12 months post-implant
Secondary outcome [6] 465503 0
Neurophysiological measurements
Timepoint [6] 465503 0
12 months post-implant

Eligibility
Key inclusion criteria
Subjects enrolled in this study must meet all of the following inclusion criteria (based on Investigator judgement):
1. Subject is planning to have a temporary SCS trial or permanent implant with the Evoke System to aid in the management of chronic intractable pain of the trunk and/or limbs
2. Overall pain score greater than or equal to 6 cm (Visual Analog Scale [VAS]).
3. 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.
4. Subject is not pregnant and not <18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
N/A

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/07/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/07/2027
Actual
Sample size
Target
40
Accrual to date
14
Final
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA

Funding & Sponsors
Funding source category [1] 321651 0
Commercial sector/Industry
Name [1] 321651 0
Saluda Medical
Country [1] 321651 0
Australia
Primary sponsor type
Individual
Name
Dr John Salmon, Pain Care Perth
Address
Country
Australia
Secondary sponsor category [1] 324472 0
Individual
Name [1] 324472 0
Dr Matthew Green, PainMedSA
Address [1] 324472 0
Country [1] 324472 0
Australia
Secondary sponsor category [2] 325219 0
Individual
Name [2] 325219 0
Ramsey Jabbour, Q Pain
Address [2] 325219 0
Country [2] 325219 0
Australia
Secondary sponsor category [3] 325491 0
Individual
Name [3] 325491 0
Martyna Berwertz, PainMedSA
Address [3] 325491 0
Country [3] 325491 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320182 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 320182 0
Ethics committee country [1] 320182 0
Australia
Date submitted for ethics approval [1] 320182 0
05/12/2024
Approval date [1] 320182 0
06/03/2025
Ethics approval number [1] 320182 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 149694 0
Dr John Salmon
Address 149694 0
Pain Care Perth. 89 Forrest St, Perth Western Australia 6011
Country 149694 0
Australia
Phone 149694 0
+61 8 92846005
Fax 149694 0
Email 149694 0
[email protected]
Contact person for public queries
Name 149695 0
Leah Muller
Address 149695 0
Saluda Medical, 5 Eden Park Drive, Macquarie Park 2113 NSW
Country 149695 0
Australia
Phone 149695 0
+61 2 8405 8700
Fax 149695 0
Email 149695 0
[email protected]
Contact person for scientific queries
Name 149696 0
Leah Muller
Address 149696 0
Saluda Medical, 5 Eden Park Drive, Macquarie Park 2113 NSW
Country 149696 0
Australia
Phone 149696 0
+61 2 84058700
Fax 149696 0
Email 149696 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.