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Completed

NCT Number: 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

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

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Key information

Conditions

Diabetic Neuropathy With Neurologic Complication Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Continuum of Care Clinic

Pine Ridge, South Dakota, 57770, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantation of a trigeminal Vagus cervical nerve stimulator system

Drug

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 stimulation

Device

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

Primary outcomes

  1. Pain scores over time

    Time frame: 90 days

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

Secondary outcomes

  1. glucose levels will be measured over time

    Time frame: 90 days

    Serum glucose levels will be followed on patients receiving neurostimulation

Sponsors and collaborators

Lead sponsor

Vagus Nerve Society

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jun 17, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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