Diabetic Neuropathy With Neurologic ComplicationNCT07025356
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 of Diabetic Neuropathy With Neurologic Complication, run by Vagus Nerve Society at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Diabetic Neuropathy With Neurologic Complication
- What is being tested?
- Implantation of a trigeminal Vagus cervical nerve stimulator system and Implantation of a neurostimulator system for trigeminal vagal cervical nerve stimulation
- Type of treatment
- Medical device
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2022to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Native American Population with Diabetic Neuropathy pain
Who may be able to join
- Diabetic Neuropathy Pain History of failed treatment WIlling to follow blood glucose and pain scores for 90 days
Who cannot join
- Bleeding diathesis Pregnancy Cardiac monitoring device Implantable Neurostimulator Inability to give informed consedn
Trial locations and contacts
1 site in 1 country.
United States1 site
Continuum of Care Clinic
Pine Ridge, South Dakota, 57770
About this study
Official title: Combined Minimally Invasive Vagal Cranial Nerve and Trigeminocervical Complex Peripheral Nerve Stimulation In Severe Painful Peripheral Neuropathy
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.
- Being tested
- Implantation of a trigeminal Vagus cervical nerve stimulator system, Implantation of a neurostimulator system for trigeminal vagal cervical nerve stimulation
- Keywords
- Vagus, diabetic neuropathy, auricular, stimulation
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Native Americans with Diabetic Neuropathy Pain | Use of Trigeminal Vagus cervical nerve stimulation for diabetic neuropathy pain Receives: Drug: Implantation of a trigeminal Vagus cervical nerve stimulator system; Device: Implantation of a neurostimulator system for trigeminal vagal cervical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores over time
Periodic pain scores will be measured for 90 days and possibly longer
Measured: 90 days
Secondary outcomes (1)
glucose levels will be measured over time
Serum glucose levels will be followed on patients receiving neurostimulation
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start23 Sep 2022
- Primary completion23 Apr 2024
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Neuropathy With Neurologic ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vagus Nerve Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Marie Rangon, MD PHD, Study director, Vagus Nerve Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025356
- Sponsor's protocol ID
- VNS 001
- Status last verified
- Jun 2025
- First submitted
- 9 Jun 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Want to maintain patient autonomy
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Minimally Invasive Vagal Cranial Nerve and Trigeminocervical Complex Peripheral Nerve Stimulation In Severe Painful Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07025356
- Acronym / sponsor ID
- VNS 001
- Keywords
- Vagus, diabetic neuropathy, auricular, stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Vagus Nerve SocietyUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Native Americans with Diabetic Neuropathy Pain | – | Drug: Implantation of a trigeminal Vagus cervical nerve stimulator system, Device: Implantation of a neurostimulator system for trigeminal vagal cervical nerve stimulationUse of Trigeminal Vagus cervical nerve stimulation for diabetic neuropathy pain |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Native American Population with Diabetic Neuropathy pain
Key inclusion criteria (1 listed)
- Diabetic Neuropathy Pain History of failed treatment WIlling to follow blood glucose and pain scores for 90 days
Key exclusion criteria (1 listed)
- Bleeding diathesis Pregnancy Cardiac monitoring device Implantable Neurostimulator Inability to give informed consedn
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of a trigeminal Vagus cervical nerve stimulator systemThe NS 100 is a medical device used for the treatment of diabetic neuropathy pain. Routine observational monitoring will be performed | Drug | Native Americans with Diabetic Neuropathy Pain |
| Implantation of a neurostimulator system for trigeminal vagal cervical nerve stimulationThe medium term outcomes of neurostimulation will be assessed on diabetic neuropathy pain, glucose and drug usage | Device | Native Americans with Diabetic Neuropathy Pain |
Primary outcome
Pain scores over time
Time frame: 90 days
Periodic pain scores will be measured for 90 days and possibly longer
1 secondary outcome
glucose levels will be measured over time
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No. Want to maintain patient autonomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Marie Rangon, MD PHD study director
Vagus Nerve Society
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Neuropathy With Neurologic Complication, run by Vagus Nerve Society at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores over time (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.