ANZCTR - Registration

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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

14/11/2019

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]

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 the legs and/or back.

Condition category

Condition code

Anaesthesiology

Pain management

Neurological

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 7-21 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]

Treatment: Devices

Comparator / control treatment

No Control Group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Change in pain scores as assessed by Visual Analogue Score and the Numeric Rating Scale

Timepoint [1]

- 3 months post permanent implant (Primary endpoint)
- 1 month
- 6 months
- 9 months
- 12 months

Secondary outcome [1]

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]

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]

Change in Quality of Life assessed by EQ5D from baseline to post implant placement

Timepoint [2]

- 1 month
- 3 months
- 6 months
-12 months

Secondary outcome [3]

Change in activities of daily living measured via the Oswestry Disability Index, from baseline to post implant placement

Timepoint [3]

- 1 month
- 3 months
- 6 months
- 12 months

Secondary outcome [4]

change in pain severity assessed via the Brief Pain Inventory, from baseline to post implant follow up

Timepoint [4]

- 1 month
- 3 months
- 6 months
- 12 months

Secondary outcome [5]

change in severity of depression as measured by the Beck's Depression Inventory from baseline to post implant placement

Timepoint [5]

- 1 month
- 3 months
- 6 months
- 12 months

Secondary outcome [6]

Impedance measured across electrodes collected and stored on the device. General descriptive statistics will be used assess this parameter.

Timepoint [6]

- 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]

Subjective outcomes include ease of use assessed by study specific questionnaires

Timepoint [7]

- baseline
- 1 month
- 3 months
- 6 months
- 9 months
- 12 months

Secondary outcome [8]

Stimulation amplitude collected and stored on the device. General descriptive statistics will be used assess this parameter.

Timepoint [8]

- trial implant placement
- permanent implant placement
- 1 months
- 3 months
- 6 months
- 9 months
- 12 months

Secondary outcome [9]

Tonic vs Nalu Stimwave stimulation collected and stored on the device. General descriptive statistics will be used assess this parameter.

Timepoint [9]

- trial implant placement
- permanent implant
- 1 month
- 3 months
- 6 months
- 9 months
- 12 months

Secondary outcome [10]

Comfort of the device assessed by study specific questionnaires

Timepoint [10]

- 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 leg and/or back; subject is unresponsive to conservative treatment options; subject has been diagnosed with failed back surgery syndrome; subject has a pain score of at least 6 on the baseline NRS pain diary; 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

Sex

Both males and females

Can healthy volunteers participate?

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

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

14/11/2018

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,SA,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Nalu Medical, Inc.

Address [1]

2320 Faraday Ave Carlsbad, California 92008 USA

Country [1]

United States of America

Primary sponsor type

Commercial sector/Industry

Name

Nalu Medical, Inc.

Address

2320 Faraday Ave
Carlsbad, California 92008

Country

United States of America

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Nalu Medical Australia PTY Ltd

Address [1]

C/-Prime Accounting and Business Advisory
Floor 19, HWT Tower
40 City Road,
Southbank
VIC 3006

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Limited

Ethics committee address [1]

129 Glen Osmond Road
Eastwood SA 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

07/11/2018

Ethics approval number [1]

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 and/or back, 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

Dr Bruce Mitchell

Address

Metro Pain Group
Monash House
Ground Floor, 271 Clayton Road
Clayton VIC 3168

Country

Australia

Phone

+61 (0) 395956111

Fax

bmitchell@metropain.com.au

Contact person for public queries

Name

Jacqui Young

Address

Metro Pain Group
Monash House
Ground Floor, 271 Clayton Road
Clayton VIC 3168

Country

Australia

Phone

+61 (0) 3 9595 6184

Fax

JYoung@monashcr.com.au

Contact person for scientific queries

Name

Jim Makous

Address

Nalu Medical, Inc. 2320 Faraday Ave Carlsbad, California 92008

Country

United States of America

Phone

+1 760 448 2366

Fax

jim@nalumed.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

Source	Title	Year of Publication	DOI
Embase	Early Experience With a Novel Miniaturized Spinal Cord Stimulation System for the Management of Chronic Intractable Pain of the Back and Legs.	2023	https://dx.doi.org/10.1016/j.neurom.2022.11.002

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically