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Trial registered on ANZCTR


Registration number
ACTRN12618001808235
Ethics application status
Approved
Date submitted
18/10/2018
Date registered
6/11/2018
Date last updated
23/11/2018
Date data sharing statement initially provided
6/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study of Evoke Spinal Cord Simulator (SCS) System in subjects with chronic pain of the upper limb and/or neck
Scientific title
A feasibility study evaluating Saluda Medical’s Spinal Cord Stimulation System incorporating feedback control to treat patients with chronic pain of upper limb and/or neck
Secondary ID [1] 296366 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic upper limb pain 310104 0
neck pain 310163 0
Condition category
Condition code
Anaesthesiology 308846 308846 0 0
Pain management
Neurological 308847 308847 0 0
Other neurological disorders
Surgery 308848 308848 0 0
Other surgery
Musculoskeletal 308916 308916 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a prospective, single arm, open-label study designed to assess the feasibility of using Evoke SCS stimulation in subjects with chronic upper-limb and/or neck pain.
Subjects with chronic, intractable upper-limb/neck pain which has been refractory to conservative therapy for a minimum of 3 months will be screened for participation in this study. Subjects who provide informed consent and meet the study eligibility criteria will first undergo a trial period with the external trial simulator for up to 30 days (typically 1 week) to determine if the subject will be eligible for the permanent implant. The leads will be removed after the trial phase and the external stimulator and the remote control will be returned to the clinic.
The trial stimulation phase involves a surgical procedure to place temporary leads (wires) into the spine. The procedure will be undertaken under anaesthesia according to the investigator’s standard practice and you may be sedated for some or the entirety of the procedure.
On average, the procedure takes about 1 hour.
The simulator will be programmed by a sponsor representative to send electrical signals to help control the pain. This may feel like a tingling sensation.
During this phase, subject may return to clinic as often as needed to get the simulator programmed. The programming might be needed for optimal pain coverage or any other technical reason. If subjects failed the trial or don’t proceed to the implant phase, they will be exited from the study.
If subject proceed to the implant phase, the procedure will take place in an operating room. The procedure will be undertaken under anaesthesia according to the investigator’s standard practice and subject may be sedated for some or the entirety of the procedure.
On average, the procedure takes about 2 hours.

Subjects will be followed up at 1-, 3-, 6-, 9-, 12, 18- and 24-months following the permanent implant.
At all of the follow-up the following will occur:
• Subject need to answer, questions about health, any taken medications/therapies or any changes in medications/therapies since last study visit.
• Subject will complete questionnaires that ask about pain, stimulation sensations, sleep, health, physical and emotional well-being, daily activities, and any limitations due to your pain.
• The study device will be tested and the settings of the study device will be changed if it is needed.
Intervention code [1] 312698 0
Treatment: Devices
Comparator / control treatment
no control group. single arm.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307821 0
feasibility as assessed by evaluation of automatic control of the SCS (using Evoked Compound Action Potential (ECAP))
Timepoint [1] 307821 0
Data will be collected during trial period and following the permanent implant on follow-up visits and unscheduled visit. follow-up visits will be after one, three, six, nine, twelve, eighteen, and twenty four months after permanent implant.
Secondary outcome [1] 353063 0
Comprehensive review of all Adverse Events (AEs) will be assessed by study specific questionnaire for evaluation of the seriousness, severity, and relatedness to the procedure, device, or stimulation therapy and any additional information related to safety reporting of a particular event will be reported by the investigator.
Timepoint [1] 353063 0
Data will be collected from the enrollment time till end of the study during trial period, following the permanent implant on follow-up visits and unscheduled visit and telephone calls. follow-up visits will be after one, three, six, nine, twelve, eighteen, and twenty four months after permanent implant.
Secondary outcome [2] 353456 0
Pain assessment (VAS)
Timepoint [2] 353456 0
Data will be collected at the trial assessment and following the permanent implant on follow-up visits. follow-up visits will be after one, three, six, nine, twelve, eighteen, and twenty four months after permanent implant.
Secondary outcome [3] 353457 0
Quality of life (EQ-5D)
Timepoint [3] 353457 0
Data will be collected at the trial assessment and following the permanent implant on follow-up visits. follow-up visits will be after one, three, six, nine, twelve, eighteen, and twenty four months after permanent implant.
Secondary outcome [4] 353458 0
Emotional functioning (POM)
Timepoint [4] 353458 0
Data will be collected at the trial assessment and following the permanent implant on follow-up visits. follow-up visits will be after one, three, six, nine, twelve, eighteen, and twenty four months after permanent implant.
Secondary outcome [5] 353460 0
physical functioning/disability (NDI)
Timepoint [5] 353460 0
Data will be collected at the trial assessment and following the permanent implant on follow-up visits. follow-up visits will be after one, three, six, nine, twelve, eighteen, and twenty four months after permanent implant.
Secondary outcome [6] 353461 0
sleep quality (PSQI)
Timepoint [6] 353461 0
Data will be collected at the trial assessment and following the permanent implant on follow-up visits. follow-up visits will be after one, three, six, nine, twelve, eighteen, and twenty four months after permanent implant.
Secondary outcome [7] 353462 0
stimulation characteristic
(custom made questionnaire about the stimulation sensation characteristics during different postures)
Timepoint [7] 353462 0
Data will be collected at the trial assessment and following the permanent implant on follow-up visits. follow-up visits will be after one, three, six, nine, twelve, eighteen, and twenty four months after permanent implant.
Secondary outcome [8] 353463 0
posture change assessment
(custom made questionnaire about he strength of the stimulation during posture change assessment in clinic)
Timepoint [8] 353463 0
Data will be collected at the trial assessment and following the permanent implant on follow-up visits. follow-up visits will be after one, three, six, nine, twelve, eighteen, and twenty four months after permanent implant.
Secondary outcome [9] 353464 0
patient global impression of change
standard questionnaire of PGIC
Timepoint [9] 353464 0
Data will be collected at the trial assessment and following the permanent implant on follow-up visits. follow-up visits will be after one, three, six, nine, twelve, eighteen, and twenty four months after permanent implant.
Secondary outcome [10] 353465 0
patient satisfaction
(custom made questionnaire about general experience of patient with the stimulator)
Timepoint [10] 353465 0
Data will be collected at the trial assessment and following the permanent implant on follow-up visits. follow-up visits will be after one, three, six, nine, twelve, eighteen, and twenty four months after permanent implant.
Secondary outcome [11] 353466 0
medication
using medical records
Timepoint [11] 353466 0
Data will be collected at the trial assessment and following the permanent implant on follow-up visits. follow-up visits will be after one, three, six, nine, twelve, eighteen, and twenty four months after permanent implant.

Eligibility
Key inclusion criteria
1. Subject has been diagnosed with chronic, intractable upper-limb/neck pain (VAS score greater or equal to 6), which has been refractory to conservative therapy for at least 6 months and subject’s predominant pain presentation is the upper-limb(s) and/or neck regions;
2. Subject has been approved by the Investigator to undergo a trial of cervical spinal cord stimulation;
3. Subject is an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician;
4. Subject is on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 30 days prior to baseline evaluation;
5. Subject is between 18 to 70 years of age at the time of consent;
6. Subject is willing and capable of giving written informed consent;
7. Subject is willing and able to comply with study-related requirements, procedures, and visits.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has a medical condition or pain in area(s) that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator;
2. Subject is not an SCS candidate due to anatomical or structural findings and/or changes which would benefit from surgical intervention (listhesis, stenosis, mechanical instability, scoliosis) as determined by investigator;
3. Subject has migraine or head pain that is the primary component of their pain syndrome (e.g. cervicogenic headache, post-herpetic neuralgia) headache, or post-herpetic neuralgia in the upper limb;
4. Subject has a history of brachial plexus avulsion;
5. Subject has undergone posterior surgical treatment of the cervical spine;
6. Subject has pain due to peripheral vascular disease or angina;
7. Subject is benefitting from an interventional procedure and/or surgery to treat upper limb pain in the last 30 days prior to baseline the evaluation;
8. Subject has evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcomes as determined by the Investigator;
9. Subject has been diagnosed with a progressive neurological disorder;
10. Subject has a history of significant untreated addiction to dependency-producing medications or have been a substance abuser (including alcohol and/or illicit drugs) in the last 6 months;
11. Subject has an existing or was previously treated with a drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS);
12. Subject is being treated with electroconvulsive therapy (ECT) or transcranial magnetic stimulation (rTMS);
13. Subject has a condition currently requiring or likely to require the use of MRI or diathermy;
14. Subject is not a good surgical candidate (e.g., has an uncontrolled coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, uncontrolled diabetes mellitus, or cannot come off anticoagulant therapy for procedure);
15. Subject has an active systemic or local infection in the area of the surgical site;
16. Subject is allergic, or has shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body;
17. Subject is immunocompromised;
18. Subject is pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control for the duration of the study, be surgically sterile or be at least 2 years post-menopausal);
19. Subject is concomitantly participating in another clinical study unless pre-approved by the sponsor;
20. Subject is involved in a process (e.g., involved in an injury claim under current litigation) in which pain relief may be considered detrimental (i.e., secondary gains);
21. Subject has a life expectancy of less than 2 years.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The study is exploratory; data will be presented using basic descriptive statistics. Multivariate regression modelling may be utilised to seek and characterise the associations between variables. No formal hypothesis testing will be performed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12201 0
Monash Surgical Private Hospital - Clayton
Recruitment hospital [2] 12202 0
Metro Pain Group - Clayton
Recruitment postcode(s) [1] 24376 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 300969 0
Commercial sector/Industry
Name [1] 300969 0
Saluda Medical
Address [1] 300969 0
Saluda Medical Pty Ltd Ground floor 407 Pacific Highway Artarmon NSW 2064
Country [1] 300969 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Saluda Medical
Address
Saluda Medical Pty Ltd Ground floor 407 Pacific Highway Artarmon NSW 2064
Country
Australia
Secondary sponsor category [1] 300548 0
None
Name [1] 300548 0
Address [1] 300548 0
Country [1] 300548 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301732 0
Bellberry
Ethics committee address [1] 301732 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 301732 0
Australia
Date submitted for ethics approval [1] 301732 0
02/10/2018
Approval date [1] 301732 0
05/11/2018
Ethics approval number [1] 301732 0

Summary
Brief summary
The purpose of the study is to investigate whether a permanent implant of a new spinal cord stimulation system, which uses automatic control, is safe and effective at treating chronic pain of the upper limbs and/or neck.
The Stimulator System being investigated in the study is similar to currently available stimulators and treats chronic pain conditions in a similar way. The differences between participating in the study and receiving a currently available stimulator system is that:
the System has technology to automatically control the strength of stimulation that you will feel;
This type of automatic control stimulation has been studied previously in Australia and the U.S. for lower-back and leg pain. A total of 163 participants have been implanted with the Evoke system so far. All the surgical procedures and medical care in this study are similar to the currently available stimulators. This study is the first time the Evoke system is tested for upper-limb and/or neck pain.
The stimulators that will be used during the study (external trial stimulator and implantable stimulator) are investigational devices that are as yet unapproved by the Department of Health, Therapeutic Goods Administration (TGA).



Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 87926 0
Dr Bruce Mitchell
Address 87926 0
Monash House, Ground floor, 271 Clayton road, Clayton VIC 3168
Country 87926 0
Australia
Phone 87926 0
+61 395956111
Fax 87926 0
Email 87926 0
bmitchell@metropain.com.au
Contact person for public queries
Name 87927 0
Dr Jacqui Young
Address 87927 0
Monash House, 271 Clayton Road, Clayton, VIC 3168
Country 87927 0
Australia
Phone 87927 0
+61 395956111
Fax 87927 0
Email 87927 0
JYoung@monashcr.com.au
Contact person for scientific queries
Name 87928 0
Dr Nastaran Hesam Shariati
Address 87928 0
Saluda Medical
Level 2, 407 Pacific Highway Artarmon NSW 2064
Country 87928 0
Australia
Phone 87928 0
+61 284058707
Fax 87928 0
Email 87928 0
nastaran.shariati@saludamedical.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No IPD data will be shared publicly.
the data will be published at the scientific and/or medical conferences or other professional forums and peer-reviewed journals. In any publication, information will be provided in such a way that participant cannot be identified. However, if participant agrees to allow the photograph and/or video to be taken and used in scientific presentations, face and other distinguishing features may be recognisable.
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable