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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

NCT07025356 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 83

Last updated 2025-06-17

No results posted yet for this study

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

Conditions

  • Diabetic Neuropathy With Neurologic Complication

Interventions

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

Sponsors & Collaborators

  • Vagus Nerve Society

    lead OTHER

Principal Investigators

  • Claire Marie Rangon, MD PHD · Vagus Nerve Society

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-23
Primary Completion
2024-04-23
Completion
2025-06-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07025356 on ClinicalTrials.gov