IRB Study Number 24-396
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Endocrinology and Metabolism Institute
Description
This is ~ 6 month study consisting of about 9 study visits and the usage and investigation of an FDA approved, nerve stimulation device.
Approximately 50 patients will be enrolled at CCF.
The purpose of the study is to evaluate the reduction of diabetic neuropathic pain for subjects with diagnosis of type I or II diabetes who suffer from moderate to severe diabetic neuropathic pain and are willing to undergo a percutaneous implantation of the NeuroSolutions 100 device and willing to wear a Continuous Glucose Monitor.
Inclusion Criteria
- between Age 18-80
- diagnosis of diabetes with clinical documentation within last 3 to 6 months of chronic moderate to severe diabetic neuropathic pain symptoms (e.g., “asleep numbness”, “prickling” or “stabbing”, ”burning” or “aching” pain) with NRS score of 5 or greater
- willing to undergo percutaneous stimulation using the NS100
- willing to wear a CGM monitoring sensor for up to 6 months and 20 days
- history of failed treatment modalities within the last three to six months for chronic pain due to diabetic neuropathy
- provide written consent
Exclusion Criteria
- any bleeding diathesis
- pregnancy
- implantable cardiac devices (i.e., pacemaker, loop recorder, defibrillator)
- cardiac monitoring devices (i.e., halter monitor)
- indwelling/implantable stimulator devices (i.e., deep brain stimulator, permanent spinal cord, bladder stimulator)
- inability to give adequate informed consent
- subject with automated insulin dosing (AID) systems.
