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CompletedNCT07025356Updated Jun 17, 2025

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

An observational study in Diabetic Neuropathy With Neurologic Complication, sponsored by Vagus Nerve Society. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-06-17.

Sponsored by Vagus Nerve Society · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
83
Ages
18 Years to 89 Years
Sex
All
01

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

Read the 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.

02

Conditions studied

  • Diabetic Neuropathy With Neurologic Complication

Keywords

  • Vagus
  • diabetic neuropathy
  • auricular
  • stimulation
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 83 is close to the median of 90 across 188 observational studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

This is the only study on the registry with Vagus Nerve Society as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Native American Population with Diabetic Neuropathy pain

Inclusion criteria

  • Diabetic Neuropathy Pain History of failed treatment WIlling to follow blood glucose and pain scores for 90 days

Exclusion criteria

Exclusion Criteria

  • Bleeding diathesis Pregnancy Cardiac monitoring device Implantable Neurostimulator Inability to give informed consedn
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
83 participants (actual)
Patient registry
No

Groups and cohorts

  • Native Americans with Diabetic Neuropathy Pain

    Use of Trigeminal Vagus cervical nerve stimulation for diabetic neuropathy pain

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

Interventions

  • DrugImplantation 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

  • DeviceImplantation 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

06

What researchers measure

Primary outcomes

  1. Pain scores over time

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

    Time frame: 90 days

Secondary outcomes

  1. glucose levels will be measured over time

    Serum glucose levels will be followed on patients receiving neurostimulation

    Time frame: 90 days

07

Study locations

1 site
  • Continuum of Care Clinic
    Pine Ridge, South Dakota 57770, United States
08

References and documents

Individual participant data

Plan to share: No — Want to maintain patient autonomy

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07025356
Lead sponsor
Vagus Nerve Society
Responsible party
Sponsor
First posted
Jun 17, 2025
Start date
Sep 23, 2022
Primary completion
Apr 23, 2024
Completion
Jun 1, 2025
Last update
Jun 17, 2025

Study contacts

Claire Marie Rangon, MD PHD
study director · Vagus Nerve Society

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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