Diabetic Neuropathy With Neurologic Complication
Conditions
Keywords
Vagus, diabetic neuropathy, auricular, stimulation
Brief summary
This is an observational study that will follow patients in the course of routine care and measure pain levels, glucose assessments and drug utilization for native American patients with diabetic neuropathy
Detailed description
Patients with diabetic neuropathy pain will have an NS100 device implanted for chronic diabetic neuropathy pain consistent with onlabel indication. All patients will be followed for 90 days post implant to measure improvements in pain, drug utilization and glucose levels.
Interventions
DRUGImplantation of a trigeminal Vagus cervical nerve stimulator system
The NS 100 is a medical device used for the treatment of diabetic neuropathy pain. Routine observational monitoring will be performed
DEVICEImplantation of a neurostimulator system for trigeminal vagal cervical nerve stimulation
The medium term outcomes of neurostimulation will be assessed on diabetic neuropathy pain, glucose and drug usage
Sponsors
Vagus Nerve Society
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Diabetic Neuropathy Pain History of failed treatment WIlling to follow blood glucose and pain scores for 90 days
Exclusion criteria
* Bleeding diathesis Pregnancy Cardiac monitoring device Implantable Neurostimulator Inability to give informed consedn
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores over time | 90 days | Periodic pain scores will be measured for 90 days and possibly longer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| glucose levels will be measured over time | 90 days | Serum glucose levels will be followed on patients receiving neurostimulation |
Countries
United States
Outcome results
None listed