None listed
Conditions
Brief summary
A clinical research to evaluate the safety and effectiveness of the Presidio Medical Low Frequency spinal cord stimulation over a 15 day period in patients with chronic, intractable low back and/or leg pain.
Interventions
The Presidio system is a form of spinal cord stimulation (SCS) that uses ultra low frequency (less than 1Hz) impulses to block the conduction of nerve pain. The participants will have epidural leads implanted for up to 15 days in an operating room setting. It will be performed by a pain management specialist surgeon in a day surgery setting under general or sedation anaesthesia with a procedure lasting approximately 1 hr. The trial system consists of epidural leads (implanted in the T6-L2 reg
The Presidio system is a form of spinal cord stimulation (SCS) that uses ultra low frequency (less than 1Hz) impulses to block the conduction of nerve pain. The participants will have epidural leads implanted for up to 15 days in an operating room setting. It will be performed by a pain management specialist surgeon in a day surgery setting under general or sedation anaesthesia with a procedure lasting approximately 1 hr. The trial system consists of epidural leads (implanted in the T6-L2 region), lead adapters, an external pulse generator (EPG)and a programming application. The participant will wear the EPG on a hip belt and will have control to continue, pause or stop stimulation. The participant will return to the clinic at days 1,3,7, and 11 to adjust their stimulation. The device is anticipated to provide near continuous stimulation throughout the trial though it is able to be paused or stopped by the participant. The entire system will be removed at Day 15. The usage data from the device will be downloaded every clinic visit to assess for total run time and device performance.
Sponsors
Presidio Medical AU, Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- literate, able to speak English and able to complete questionnaires independently. - Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol. - have been diagnosed with chronic, intractable pain of the low back and/or legs (VAS greater than or equal to 60mm for the past week) which has been refractory to conservative therapy for a minimum of 3 months. - Are currently receiving optimal medical management and considered medically stable as judged by the investigator. - Able to change AA batteries and operate the EPG.
Exclusion criteria
1 If female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least two years post-menopausal 2. IV Contrast allergy 3. Severe cognitive impairment as determined by investigator 4. A psychological assessment will be performed at Baseline to exclude an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome. This will be performed by the investigator in consultation with a clinical psychologist if applicable 5. Pre-existing motor, balance, proprioception, or sensory deficits as determined by investigator 6. Spinal Stenosis or other structural spinal abnormality observed on MRI that would make lead placement unsafe or untowardly difficult as determined by investigator 7. Currently taking anticoagulants including Warfarin, Heparin, Low Molecular Weight Heparin, Factor Xa inhibitors, GPIIb/IIIa inhibitors, thienopyridine inhibitors, direct thrombin inhibitors, or any other anticoagulant that is a contraindication to epidural lead placement within 1 week of the Screening Visit 8. Current coagulopathy, thrombocytopenia or bleeding diathesis (confirmed by clinical history and, if clinically indicated, by coagulation screening) 9. Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device 10. A systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, etc.) 11. Known hypersensitivity to any of the procedural agents or materials in the study device that is inserted into the subject 12. Previous non-responder to spinal cord stimulation
Outcome results
None listed