JRCT ID: jRCTs032220332
Registered date:13/09/2022
Exploration of evaluation indices for taVNS
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | N/A |
Date of first enrollment | 19/10/2022 |
Target sample size | 10 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | transcutaneous auricular Vagus Nerve Stimulation |
Outcome(s)
Primary Outcome | Change ratio of heart rate |
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Secondary Outcome | 1. Change ratio of heart rate variability (HRV) 2. Change ratio of pupil diameter 3. Brain MRI image change 4. Heart rate counting task (HCT) 5. Multidimensional Assessment of Interoceptive Awareness (MAIA) Japanese version 6. STAI State-Trait Anxiety Inventory Japanese version 7. Japanese version of the SSS-8 |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | <= 39age old |
Gender | Male |
Include criteria | 1) Persons who are 20 to 39 or below at the time of consent 2) Healthy male |
Exclude criteria | 1) Patients with cochlear implants, cardiac pacemakers, or implanted VNS 2) Those with certain risks associated with MRI imaging (tattoos, art makeup, claustrophobia, etc.) 3) Those with injuries to the auricular region 4) Those who have undergone a myeloscopic shunt procedure 5) Patients with a diagnosis of glaucoma 6) Persons who smoke 7) Those requiring regular medication 8) Those who have consumed caffeinated beverages (coffee, black tea, green tea, energy drinks, etc.) on or after the day before the test 9) Other persons deemed inappropriate by the principal investigator |
Related Information
Primary Sponsor | SEKIGUCHI Atsushi |
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Secondary Sponsor | |
Source(s) of Monetary Support | National Center of Neurology and Psychiatry,Japan Agency for Medical Research and Development |
Secondary ID(s) |
Contact
Public contact | |
Name | Atsushi SEKIGUCHI |
Address | 4-1-1 Ogawahigashi, Kodaira, Tokyo Tokyo Japan 187-8553 |
Telephone | +81-42-341-2711 |
asekiguchi@ncnp.go.jp | |
Affiliation | National Center of Neurology and Psychiatry |
Scientific contact | |
Name | Atsushi SEKIGUCHI |
Address | 4-1-1 Ogawahigashi, Kodaira, Tokyo Tokyo Japan 187-8553 |
Telephone | +81-42-341-2711 |
asekiguchi@ncnp.go.jp | |
Affiliation | National Center of Neurology and Psychiatry |