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Trial registered on ANZCTR


Registration number
ACTRN12618001862235
Ethics application status
Approved
Date submitted
11/11/2018
Date registered
15/11/2018
Date last updated
15/11/2018
Date data sharing statement initially provided
15/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Spinal Cord Stimulation in the treatment of chronic, intractable pain using the Nalu Neurostimulation System in adults
Scientific title
A multi-center, prospective, open label , feasibility study to evaluate Spinal Cord stimulation, in the treatment of chronic, intractable pain, using the Nalu Neurostimulation System, in adult patients.
Secondary ID [1] 296561 0
NAL-01-2018-AUS
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Intractable Neuropathic Pain of lower limbs with or without back pain 310347 0
Condition category
Condition code
Anaesthesiology 309076 309076 0 0
Pain management
Neurological 309107 309107 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Nalu Neurostimulation System is an implantable medical device that is designed as an adjunctive therapy to medical management in patients with chronic pain. The system incorporates a battery-free, miniature implantable pulse generator (IPG), powered by an externally worn device (Therapy Disc). Commercially available leads are placed in the epidural space to deliver electric stimulation to the dorsal columns of the spinal cord. The stimulation parameters are set (programs) using a Clinical Programming application by a Field Clinical Engineer in consultation with the subject's doctor. The patient is able to set programs using a Remote Control which is available as a Remote Control Application.
As with other commercially available systems, the Nalu Neurostimulation System provides a Trial Period, to allow the patient to experience the therapy for a short time (commonly 3-30 days) before committing to long term implant. During such trials, stimulation contacts on a lead are deployed into the epidural space using minimally invasive techniques. Per the study protocol, 3 methods are available for trial period: Temporary Trial, Permanent Trials and IPG Trials. In this study, the trial period will last for 7-14 days from Trial Procedure to completion of Trial Phase. This is based on the clinician preference and to allow clinician to align with standard of care. The intent is to allow physicians to choose the method that most closely mirrors their current practice. The decision as to which will be used for each particular study participant will be based upon the Investigator’s standard clinical practice and preferred choice for that patient:
1) Temporary trials: During the trial phase, each lead is percutaneously externalized and connected to the Trial Therapy Disc directly to deliver therapy. After a successful trial phase, the trial leads are removed, and new leads are permanently implanted with the IPG. The implantation of the IPG may occur within a few days or weeks of the lead removal.
2) Permanent trials: During the trial phase, the lead is anchored under the skin, and connected to a lead extension. The lead extension is percutaneously externalized and connected to the Trial Therapy Disc to deliver therapy. After a successful trial phase, the extension is removed, but the leads remain in place, and the IPG is implanted and connected to the implanted leads. The implantation of the IPG may occur within a few days or weeks of the lead removal.
3) IPG trials: During the trial phase, the leads and IPG are both implanted. After the trial phase, if the trial was successful, the subject moves directly to the permanent implant phase without an additional surgical procedure. If the trial is not successful, then the leads and IPG are removed. This option allows for successful trial patients to avoid an additional surgical procedure.
On successful completion of the trial phase, a permanent implant is placed. Per protocol, the permanent implant is placed within 0-30 days on completion of the Trial Phase. The procedure is done under local anesthesia and fluoroscopic guidance. The permanent leads are advanced to the appropriate vertebral level with a sufficient length of lead in the epidural space to aid in lead stabilization. A lead anchor is used to secure the leads; the proximal end of the lead is inserted into the proximal end of the IPG connector and locked. The Therapy Disc, in a sterile bag, is placed over the implanted IPG and test stimulation is performed while verifying the response. The final location of the IPG pocket site is determined through consultation with patient prior to the surgery. Sutures are placed to close the incision. The Therapy Discs are programmed the day after surgery before patient discharge.
Study subjects will visit the clinic for follow up at 2 weeks, 1 month, 3 months, 6 months, 9 months and 12 months post permanent implants. Unscheduled visits may occur throughout the study in order to adjust programming parameters. Subjects will be administered VAS and NRS for pain scores, as well as quality of life questionnaires at screening and follow-up.
Intervention code [1] 312866 0
Treatment: Devices
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308064 0
Change in pain scores as assessed by Visual Analogue Score and the Numeric Rating Scale
Timepoint [1] 308064 0
- 3 months post permanent implant (Primary endpoint)
- 1 month
- 6 months
- 9 months
- 12 months
Secondary outcome [1] 353854 0
Safety of the Nalu Neurostimulation System assessed via adverse events recorded. Adverse events will be collected via
- patient reported events
- solicitation of AEs during study visits
- medical records
- x-rays taken during study visits

Adverse Events include but not limited to lead migration, undesirable changes in stimulation sensation and or location with or without patient movement, undesirable skin problems such as infection, irritation, blistering, tearing or allergic reactions to to the wearable component, redness and itchiness.
Timepoint [1] 353854 0
Adverse Events will be assessed at
- screening and baseline
- during trial phase
- at permanent implant surgery
- 2 weeks post surgery
- 1 month post surgery
- 3 months, 6 months, 9 months and 12 months post surgery
Secondary outcome [2] 353899 0
Change in Quality of Life assessed by EQ5D from baseline to post implant placement
Timepoint [2] 353899 0
- 1 month
- 3 months
- 6 months
-12 months
Secondary outcome [3] 353900 0
Change in activities of daily living measured via the Oswestry Disability Index, from baseline to post implant placement
Timepoint [3] 353900 0
- 1 month
- 3 months
- 6 months
- 12 months
Secondary outcome [4] 353901 0
change in pain severity assessed via the Brief Pain Inventory, from baseline to post implant follow up
Timepoint [4] 353901 0
- 1 month
- 3 months
- 6 months
- 12 months
Secondary outcome [5] 353902 0
change in severity of depression as measured by the Beck's Depression Inventory from baseline to post implant placement
Timepoint [5] 353902 0
- 1 month
- 3 months
- 6 months
- 12 months
Secondary outcome [6] 353903 0
Impedance measured across electrodes collected and stored on the device. General descriptive statistics will be used assess this parameter.
Timepoint [6] 353903 0
- Trial Implant placement
- Permanent Implant
- 1 month follow up
- 3 months follow up
- 6 months follow up
- 9 months follow up
- 12 months follow up
Secondary outcome [7] 353904 0
Subjective outcomes include ease of use assessed by study specific questionnaires
Timepoint [7] 353904 0
- baseline
- 1 month
- 3 months
- 6 months
- 9 months
- 12 months
Secondary outcome [8] 353989 0
Stimulation amplitude collected and stored on the device. General descriptive statistics will be used assess this parameter.
Timepoint [8] 353989 0
- trial implant placement
- permanent implant placement
- 1 months
- 3 months
- 6 months
- 9 months
- 12 months
Secondary outcome [9] 353990 0
Tonic vs Nalu Stimwave stimulation collected and stored on the device. General descriptive statistics will be used assess this parameter.
Timepoint [9] 353990 0
- trial implant placement
- permanent implant
- 1 month
- 3 months
- 6 months
- 9 months
- 12 months
Secondary outcome [10] 353991 0
Comfort of the device assessed by study specific questionnaires
Timepoint [10] 353991 0
- baseline
- 1 months
- 3 months
- 6 months
- 9 months
- 12 months

Eligibility
Key inclusion criteria
Subjects between 21-80 years of age; subjects who have chronic (at least 6 months) intractable neuropathic pain of the lower limbs with or without back pain; subject is unresponsive to conservative treatment options; subject has been diagnosed with failed back surgery syndrome; subject has at least 60mm on the office-based VAS for pain specific to the legs over the preceding 24 hours, at Visit 1; subject has stable pain medication use and dosage for at least 30 days prior to consent; subject has reported stable non-escalating pain for at least 30 days before consent.
Minimum age
21 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subject currently has an active implantable medical device such as a drug pump, spinal cord stimulator, sacral nerve stimulator, deep brain stimulator, and/or cardiac pacemaker; subject has previously failed SCS therapy; subject has ablative procedure directed at the spinal cord including dorsal root entry zone (DREZ); subject has mechanical spinal instability detected by > 4 mm translational movement or excessive angular movement manifested by 20 degrees greater angular movement than in an adjacent segment based on flexion/extension films of lumbar spine, subject is sensitive to skin adhesives used in the system or does not tolerate wearable aspects of the device; subject has a systemic infection; subject is unable to give informed consent; subject is pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 1 year post menopausal); subject is nursing or breastfeeding; subject is > 120 mg-morphine equivalents per 24 hours.

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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
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)
NSW,QLD,WA,VIC
Recruitment outside Australia
Country [1] 21015 0
New Zealand
State/province [1] 21015 0

Funding & Sponsors
Funding source category [1] 301140 0
Commercial sector/Industry
Name [1] 301140 0
Nalu Medical, Inc.
Address [1] 301140 0
1525 Faraday Ave
Carlsbad, California 92008
USA
Country [1] 301140 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Nalu Medical, Inc.
Address
1525 Faraday Ave
Carlsbad, California 92008
USA
Country
United States of America
Secondary sponsor category [1] 300760 0
Commercial sector/Industry
Name [1] 300760 0
Nalu Medical Australia PTY Ltd
Address [1] 300760 0
C/-Prime Accounting and Business Advisory
Floor 19, HWT Tower
40 City Road,
Southbank
VIC 3006
Country [1] 300760 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301889 0
Bellberry Limited
Ethics committee address [1] 301889 0
129 Glen Osmond Road
Eastwood SA 5063
Ethics committee country [1] 301889 0
Australia
Date submitted for ethics approval [1] 301889 0
Approval date [1] 301889 0
07/11/2018
Ethics approval number [1] 301889 0

Summary
Brief summary
The Nalu Neurostimulation System is indicated as an aid in the management of chronic intractable pain. The study will enroll adults between 21 and 80 years of age with chronic intractable pain in the legs, with or without back pain, who meet the inclusion and exclusion criteria of the study. The primary study objective is to confirm the performance of the Nalu Neurostimulation System in patients with chronic pain. Additionally, multiple standard outcome domains will be captured to confirm system performance and patient responses to the device and therapy. Data will also be collected to support a safety endpoint.
The study is a prospective, multicenter, open label, feasibility clinical study. The study will include three phases: Screening/baseline, SCS Trial, and Permanent Implant. Study subjects will be followed up for 12 months after device implantation. The study is expected to take 2 years from first enrollment to last follow up of last patient and subsequent study closure. Upto 40 subjects will be implanted with the device across 10 centers in Australia and New Zealand. Performance measures include Pain Scores(VAS, Numeric Rating Scale, in-office and at home); Quality of Life using the EQ5D, Activities of Daily Living (Oswestry Disability Index, ODI), Pain and paresthesia maps, pain medication use, procedure information, ease of use of the wearable components, Brief Pain Inventory and the Beck's Depression Index. This study is not formally powered as it is a feasibility study. basic statistical analyses will be completed on all endpoints including computation of average, variance , standard deviations and trend analysis. Secondary Objective data may be qualitative only.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88450 0
Dr Bruce Mitchell
Address 88450 0
Metro Pain Group
Monash House
Ground Floor, 271 Clayton Road
Clayton VIC 3168
Country 88450 0
Australia
Phone 88450 0
+61 (0) 395956111
Fax 88450 0
Email 88450 0
bmitchell@metropain.com.au
Contact person for public queries
Name 88451 0
Dr Jacqui Young
Address 88451 0
Metro Pain Group
Monash House
Ground Floor, 271 Clayton Road
Clayton VIC 3168
Country 88451 0
Australia
Phone 88451 0
+61 (0) 3 9595 6184
Fax 88451 0
Email 88451 0
JYoung@monashcr.com.au
Contact person for scientific queries
Name 88452 0
Mr Jim Makous
Address 88452 0
Nalu Medical, Inc.
1525 Faraday Ave
Carlsbad, California 92008
Country 88452 0
United States of America
Phone 88452 0
+1 760 448 2366
Fax 88452 0
Email 88452 0
jim@nalumed.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results