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 | Completed FDA Device

• 1 other identifier: VNS 001
• Study Type: observational
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vagus; diabetic neuropathy; auricular; stimulation

Outcome Measures

Primary Outcomes (1)

• Pain scores over time

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

  90 days

Secondary Outcomes (1)

• glucose levels will be measured over time

  90 days

Study Arms (1)

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

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

Native Americans with Diabetic Neuropathy Pain

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

Native Americans with Diabetic Neuropathy Pain

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Native American Population with Diabetic Neuropathy pain

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vagus Nerve Society: lead

Study Sites (1)

Continuum of Care Clinic

Pine Ridge, South Dakota, 57770, United States

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Claire Marie Rangon, MD PHD

  Vagus Nerve Society

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: September 23, 2022
• Primary Completion: April 23, 2024
• Study Completion: June 1, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)