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Transcutaneous Auricular Vagus Nerve Stimulation in Type 2 Diabetes With Mild Cognitive Impairment
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Summary
This study is a 24-week, single-center, randomized, double-blind, sham-controlled, parallel-group clinical trial. A total of 38 patients with type 2 diabetes and mild cognitive impairment were enrolled and randomly assigned in a 1:1 ratio to either the treatment group (receiving active transcutaneous auricular vagus nerve stimulation) or the sham control group (receiving sham transcutaneous auricular vagus nerve stimulation). The primary objective of this study is to evaluate the potential disease-modifying effects of transcutaneous auricular vagus nerve stimulation on cognitive impairment in patients with type 2 diabetes.
Official title: Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Type 2 Diabetes and Mild Cognitive Impairment: A Single-Center, Randomized, Double-Blind, Sham-Controlled Clinical Trial
Key Details
Gender
All
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
38
Start Date
2026-05-20
Completion Date
2027-12-31
Last Updated
2026-06-11
Healthy Volunteers
No
Conditions
Interventions
active transcutaneous auricular vagus nerve stimulation
After disinfecting the stimulation sites (cymba conchae, cavum conchae, and earlobe), the auricular stimulation electrodes will be attached. For the active stimulation group, the actual functional electrodes delivering the current are positioned at the cymba conchae and cavum conchae. The stimulation parameters are set as follows:(1) Dense-disperse wave, with a stimulation frequency consisting of 20 Hz pulses for 10 seconds and 100 Hz pulses for 50 seconds per minute, and a pulse width of 0.2 ms ± 30%;(2) Stimulation intensity ranging from 4 to 6 mA, adjusted according to the individual patient's tolerance;(3) 30 minutes per session, twice daily;(4) 5 days per week, for 24 weeks.
sham transcutaneous auricular vagus nerve stimulation
After disinfecting the stimulation sites (cymba conchae, cavum conchae, and earlobe), the auricular stimulation electrodes will be attached. For the sham stimulation group, the actual functional electrodes delivering the current are positioned at the earlobe. The stimulation parameters are set as follows:(1) Dense-disperse wave, with a stimulation frequency consisting of 20 Hz pulses for 10 seconds and 100 Hz pulses for 50 seconds per minute, and a pulse width of 0.2 ms ± 30%;(2) Stimulation intensity ranging from 4 to 6 mA, adjusted according to the individual patient's tolerance;(3) 30 minutes per session, twice daily;(4) 5 days per week, for 24 weeks.