NCT07025356

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

Combined Minimally Invasive Vagal Cranial Nerve and Trigeminocervical Complex Peripheral Nerve Stimulation In Severe Painful Peripheral Neuropathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 83 (actual)
• Sponsor: Vagus Nerve Society · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Neuropathy With Neurologic Complication

Interventions

Type	Name	Description
DRUG	Implantation 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
DEVICE	Implantation 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

Timeline

• Start date: 2022-09-23
• Primary completion: 2024-04-23
• Completion: 2025-06-01
• First posted: 2025-06-17
• Last updated: 2025-06-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study