UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059680 |
|---|---|
| Receipt number | R000068266 |
| Scientific Title | Effects of Different Stimulation Intensities of Transcutaneous Auricular Vagus Nerve Stimulation on Changes in the Functional State of the Locus Coeruleus-Noradrenaline System During Cognitive Activity: A Single-Blind Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2025/11/07 11:57:14 |
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Basic information
Public title
Effects of Different Stimulation Intensities of Transcutaneous Auricular Vagus Nerve Stimulation on Changes in the Functional State of the Locus Coeruleus-Noradrenaline System During Cognitive Activity: A Single-Blind Randomized Controlled Trial
Acronym
Effects of Different Stimulation Intensities of Transcutaneous Auricular Vagus Nerve Stimulation on Changes in the Functional State of the Locus Coeruleus-Noradrenaline System During Cognitive Activity: A Single-Blind Randomized Controlled Trial
Scientific Title
Effects of Different Stimulation Intensities of Transcutaneous Auricular Vagus Nerve Stimulation on Changes in the Functional State of the Locus Coeruleus-Noradrenaline System During Cognitive Activity: A Single-Blind Randomized Controlled Trial
Scientific Title:Acronym
Effects of Different Stimulation Intensities of Transcutaneous Auricular Vagus Nerve Stimulation on Changes in the Functional State of the Locus Coeruleus-Noradrenaline System During Cognitive Activity: A Single-Blind Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether cognitive performance and the functional state of the locus coeruleus-norepinephrine differ among three groups classified by a single-blind randomized controlled trial: a group receiving stimulation at an intensity set by the threshold method, a group receiving stimulation at 0.5 mA, and a control group receiving no stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Event-related potential
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Individually adjusted intensity transcutaneous auricular vagus nerve stimulation
Interventions/Control_2
Transcutaneous auricular vagus nerve stimulation at 0.5mA intensity
Interventions/Control_3
Non-irritating
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Native language is Japanese
Right-handed
Key exclusion criteria
History of epileptic seizures or family history
Presence of neurological, psychiatric, or cardiac disorders
History of external ear trauma
Presence of internal implants
Regular use of medications
Pregnancy
Alcohol or drug dependence
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Annaka |
Organization
Niigata University of Health and Welfare
Division name
Department of Occupational Therapy
Zip code
950-3198
Address
1938, Shimami-chou, Kita-ku, Niigata
TEL
025-257-4437
hiroki-annaka@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Annaka |
Organization
Niigata University of Health and Welfare
Division name
Department of Occupational Therapy
Zip code
950-3198
Address
1938, Shimami-chou, Kita-ku, Niigata
TEL
025-257-4437
Homepage URL
hiroki-annaka@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1938, Shimami-chou, Kita-ku, Niigata
Tel
025-257-4437
hiroki-annaka@nuhw.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 11 | Month | 07 | Day |
Last modified on
| 2025 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068266
