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
NCT ID: NCT07025356
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
83 participants
OBSERVATIONAL
2022-09-23
2025-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Native Americans with Diabetic Neuropathy Pain
Use of Trigeminal Vagus cervical nerve stimulation for diabetic neuropathy pain
Implantation 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
Implantation 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
Interventions
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Implantation 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
Implantation 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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
89 Years
ALL
No
Sponsors
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Vagus Nerve Society
OTHER
Responsible Party
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Principal Investigators
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Claire Marie Rangon, MD PHD
Role: STUDY_DIRECTOR
Vagus Nerve Society
Locations
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Continuum of Care Clinic
Pine Ridge, South Dakota, United States
Countries
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Other Identifiers
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VNS 001
Identifier Type: -
Identifier Source: org_study_id
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