None listed
Conditions
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.
Interventions
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 Pr
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
Sponsors
Nalu Medical, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 80 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed