Observational Study of the the Use of a Trigeminal Vagal... | NCT07025356

Studies
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

Sponsor

Vagus Nerve Society

Status

Completed

Last Update Posted

Jun 17, 2025Actual

Enrollment

83Actual

Phase

Not provided

Conditions

Diabetic Neuropathy With Neurologic Complication

Interventions

Implantation of a trigeminal Vagus cervical nerve stimulator system
Implantation of a neurostimulator system for trigeminal vagal cervical nerve stimulation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jun 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 23, 2022Actual

Primary Completion Date

Apr 23, 2024Actual

Completion Date

Jun 1, 2025Actual

First Submitted Date

Jun 9, 2025

First Submission Date that Met QC Criteria

Jun 9, 2025

First Posted Date

Jun 17, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2025

Last Update Posted Date

Jun 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

83Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain scores over time	Periodic pain scores will be measured for 90 days and possibly longer	90 days

Secondary Outcomes

Measure	Description	Time Frame
glucose levels will be measured over time	Serum glucose levels will be followed on patients receiving neurostimulation	90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Native American Population with Diabetic Neuropathy pain

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claire Marie Rangon, MD PHD	Vagus Nerve Society	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Continuum of Care Clinic		Pine Ridge	South Dakota	57770	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Want to maintain patient autonomy

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases
D048909	Diabetes Complications
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases