NCT07025356View on ClinicalTrials.gov

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

CompletedOBSERVATIONAL
Enrollment

83

Participants

Timeline

Start Date

September 23, 2022

Primary Completion Date

April 23, 2024

Study Completion Date

June 1, 2025

Conditions
Diabetic Neuropathy With Neurologic Complication
Interventions
DRUG

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

DEVICE

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

Trial Locations (1)

57770

Continuum of Care Clinic, Pine Ridge

All Listed Sponsors
lead

Vagus Nerve Society

OTHER