Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Neuropathy With Neurologic Complication

Keywords

Vagusdiabetic neuropathyauricularstimulation

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 systemDevice: Implantation of a neurostimulator system for trigeminal vagal cervical nerve stimulation

Interventions

Implantation of a trigeminal Vagus cervical nerve stimulator systemDrug

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 stimulationDevice

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

Eligibility Criteria

Age18 Years - 89 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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:

Sponsors & Collaborators

Vagus Nerve Society
Otherlead

Study Sites (1)

Continuum of Care Clinic

Pine Ridge, South Dakota, 57770, United States

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

Claire Marie Rangon, MD PHD
Vagus Nerve Society
STUDY DIRECTOR

Enrollment

83 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Native Americans with Diabetic Neuropathy Pain

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Native Americans with Diabetic Neuropathy Pain

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations