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Japanese

Feb. 22, 2023

Sept. 06, 2024

jRCT1040220145

Neural responses to transcutaneous auricular vagus nerve stimulation in the nucleus of solitary tract, locus coeruleus and cerebral cortex

Neural responses to transcutaneous auricular vagus nerve stimulation in the nucleus of solitary tract, locus coeruleus and cerebral cortex

Harada Tokiko

Nagoya University

Furo-cho, Chikusa-ku, Nagoya, Aichi

+81-52-789-2223

tokikoh@gmail.com

Harada Tokiko

Nagoya University

Furo-cho, Chikusa-ku, Nagoya, Aichi

+81-52-789-2223

tokikoh@gmail.com

Recruiting

Feb. 22, 2023

Sept. 04, 2024
35

Interventional

single arm study

open(masking not used)

placebo control

crossover assignment

basic science

1. Healthy adults who do not meet the exclusion criteria
2. right-handed
3. Japanese native speakers
4. Those who wish to participate in the research, fully understand the content of the research and have obtained written consent

1. Persons who have an interest in the principal investigator or co-investigator (e.g., graduate school students, students taking classes, etc.)
2. People with metal objects such as heart, nerve pacemakers, artery clips, etc.
3. People who have had a metal clip inserted due to an injury (because there is a possibility of residual metal in the body)
4. People who have a history of metal processing (because there is a possibility of residual metal in the body)
5. Those who are wearing orthodontic appliances or have metal implants (fillings and crowns are acceptable even with metal)
6. Persons wearing non-removable metal (eyelash extensions, nail parts, wigs, etc.)
7. people who have had brain surgery
8. People who have or have a history of mental illness
9. People with a history of claustrophobia or fear of the dark
10. Those who have a history of hernia, etc. and cannot maintain the same posture for a long time
11. Persons with visual impairment that interferes with daily life (excluding cases where the use of glasses or contact lenses does not interfere with daily life) or hearing impairment
12. People taking drugs (cold remedies, drugs that control the action of neurotransmitters, etc.)
13. People who cannot use both hands due to injury (because they will be pressing buttons in the experiment)
14. pregnant or possibly pregnant

18age old over
39age old under

Both

Healthy adults, expected effect; transient activation of relevant brain regions

Intervention type: Transcutaneous auricular vagus nerve stimulation
Stimulation site: tragus, earlobe (control condition)
Stimulation parameters: frequency 1-25 Hz, pulse width 100-500 microsecond
Stimulus intensity: subthreshold (stimulation intensity slightly weaker than the intensity at which the stimulus is perceived), sensory threshold (stimulation intensity slightly higher than the intensity at which the stimulus is felt), and pain threshold (slightly weaker than the intensity at which the stimulus is perceived as painful)
Amount of stimulation, frequency, etc.: The duration of continuous stimulation is 30 to 120 seconds, and a rest period of 20 seconds or more is provided between each continuous stimulation.The maximum number of stimuli is 10 for each of 6 stimulus conditions (2 stimulus locations, 3 stimulus intensities).However, if only some of the six stimulation conditions are used, the total number of stimulations for all stimulation conditions may be set to 60 times throughout the experiment, and the number of stimulations for each stimulation condition may be set to 10 times or more.

Healthy adults

transcutaneous auricular vagus nerve stimulation, taVNS

Changes in brain activity measured by functional magnetic resonance imaging during transcutaneous auricular vagus nerve stimulation

Changes in heart rate and pupillary diameter during transcutaneous auricular vagus nerve stimulation

Nagoya University
Ethical Review Committee for departments in Higashiyama Campus, Nagoya University
Furo-cho, Chikusa-ku, Nagoya, Aichi, Aichi

+81-52-747-6372

kenkyu-anzen@adm.nagoya-u.ac.jp
Approval

Mar. 08, 2023

No

none

History of Changes

No Publication date
3 Sept. 06, 2024 (this page) Changes
2 June. 14, 2024 Detail Changes
1 Feb. 22, 2023 Detail