None listed
Conditions
Brief summary
This study seeks to evaluate the safety and effectiveness of an experimental type of spinal cord stimulator. The device is not yet approved for use in Australia for the treatment of Painful Diabetic Neuropathy. The experimental device is used for 15 days and is then removed. The experimental stimulator delivers a different wavelength that other traditional spinal cord stimulators and it may help to alleviate pain.
Interventions
The purpose of this study is to evaluate the safety and effectiveness of the Presidio Medical ULF-SCS over a 15-day period in subjects with Painful Diabetic Neuropathy.
The Presidio Medical ULF-SCS system is a form of spinal cord stimulation (SCS) that uses ultra low frequency (less than 1Hz) electrical currents to the epidural space to modulate 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 performe
The purpose of this study is to evaluate the safety and effectiveness of the Presidio Medical ULF-SCS over a 15-day period in subjects with Painful Diabetic Neuropathy. The Presidio Medical ULF-SCS system is a form of spinal cord stimulation (SCS) that uses ultra low frequency (less than 1Hz) electrical currents to the epidural space to modulate 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 T8-T10 region), lead adapters, an external pulse generator (EPG), surface electrodes, 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 and 7 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 at every clinic visit to assess for total run time and device performance. The stimulation may be paused in the following instances: taking a sponge bath or driving.
Sponsors
Presidio Medical AU Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have been diagnosed with lower extremity painful diabetic neuropathy for a minimum of 3 months 2. VAS greater than or equal to 50mm for the past week 3. Have stable neurological status 4. Eighteen (18) years of age or older 5. Literate, able to speak English and able to complete questionnaires independently 6. Willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol 7. Are currently receiving optimal medical management and considered medically stable as judged by investigator 8. Ability to independently change AA batteries and operate EPG. 9. Able to comply with study requirements and attend all scheduled visits
Exclusion criteria
1. Have a diagnosis of a lower limb mononeuropathy, have had a lower limb amputation, or have ulcers of the lower limbs 2. If female and sexually active, and the subject is not using a reliable form of birth control, is not surgically sterile or at least two years post-menopausal, the subject shall be excluded, as confirmed by the investigator 3. A Hemoglobin A1C (HgB A1C) level that is greater than (>) 9% 4. Body Mass Index (BMI) score that is > 40 5. Diagnosis of Fibromyalgia 6. VAS greater than or equal to 30mm in the legs or trunk that would make accurate assessment of change difficult, as determined by investigator. 7. Severe cognitive impairment as determined by investigator 8. Average total daily morphine equivalent dose (MED) of >100 mg 9. A psychological assessment will be performed at Baseline to exclude any diagnosis of active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance, intervention and/or ability to evaluate treatment outcome as assessed by a clinical psychologist or psychiatrist. 10. Spinal stenosis or other structural spinal abnormality observed on MRI (or CT scan) that would make lead placement unsafe or untowardly difficult as determined by investigator 11. 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 12. Current coagulopathy, thrombocytopenia or bleeding diathesis (confirmed by clinical history and, if clinically indicated, by coagulation screening) 13. Cardiac demand pacemaker, implanted defibrillator or another implanted electronic device 14. 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.) 15. Known hypersensitivity to any of the procedural agents or materials in the study device that is inserted into the subject 16. Previous use of spinal cord stimulation or comparable therapy 17. A known need for an MRI or surgery between the screening visit through the end of the study. 18. Any experimental drug or device used within 30 days prior to the Screening Visit or during the course of the clinical trial 19. Subjects who are involved in ongoing or closed (within 30 days of the screening visit) litigation related to their pain condition
Outcome results
None listed