Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07642518
NA

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

View on ClinicalTrials.gov

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

Interventions

DEVICE

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.

DEVICE

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.