Observational Study of the the Use of a Trigeminal Vagal Nerve Stimulator in the Routine Care of Native Americans With Diabetic Neuropathy Pain. Pain Scores, Drug Use and Glucose Measurements Will be Assessed

Vagus Nerve Society83 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetic Neuropathy With Neurologic Complication

Interventions

Implantation of a trigeminal Vagus cervical nerve stimulator systemDRUG

The NS 100 is a medical device used for the treatment of diabetic neuropathy pain. Routine observational monitoring will be performed

Implantation of a neurostimulator system for trigeminal vagal cervical nerve stimulationDEVICE

The medium term outcomes of neurostimulation will be assessed on diabetic neuropathy pain, glucose and drug usage

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (1)

Continuum of Care Clinic

Pine Ridge, South Dakota, United States

Outcomes

Primary Outcomes

Pain scores over time

Periodic pain scores will be measured for 90 days and possibly longer

Time frame: 90 days

Secondary Outcomes

glucose levels will be measured over time

Serum glucose levels will be followed on patients receiving neurostimulation

Time frame: 90 days

Data from ClinicalTrials.gov

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