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 Society

Status: Completed

Conditions: Diabetic Neuropathy With Neurologic Complication

Treatments: Drug: Implantation of a trigeminal Vagus cervical nerve stimulator system; Device: Implantation of a neurostimulator system for trigeminal vagal cervical nerve stimulation

Study type: Observational

Funder types: Other

Identifiers

NCT07025356

VNS 001

Details and patient eligibility

About

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

Full 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.

Enrollment: 83 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

83 participants in 1 patient group

Native Americans with Diabetic Neuropathy Pain

Description:

Use of Trigeminal Vagus cervical nerve stimulation for diabetic neuropathy pain

Treatment:

Device: Implantation of a neurostimulator system for trigeminal vagal cervical nerve stimulation

Drug: Implantation of a trigeminal Vagus cervical nerve stimulator system