UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051679 |
|---|---|
| Receipt number | R000058519 |
| Scientific Title | Effect of transauricular vagus nerve stimulation on short-latency cholinergic afferent inhibition |
| Date of disclosure of the study information | 2023/07/21 |
| Last modified on | 2024/04/01 07:54:08 |
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Basic information
Public title
Effect of transauricular vagus nerve stimulation on short-latency cholinergic afferent inhibition
Acronym
Effect of transauricular vagus nerve stimulation on short-latency cholinergic afferent inhibition
Scientific Title
Effect of transauricular vagus nerve stimulation on short-latency cholinergic afferent inhibition
Scientific Title:Acronym
Effect of transauricular vagus nerve stimulation on short-latency cholinergic afferent inhibition
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of transauricular vagus nerve stimulation on cholinergic neural circuits
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Short interval afferent inhibition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Continuous transauricular vagus nerve stimulation
Interventions/Control_2
Intermittent transauricular vagus nerve stimulation
Interventions/Control_3
Sham stimulation
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Healthy adults who have applied for participation in this study through posters posted in the Hiroshima University Health Sciences Research Building.
*The age at the time of consent acquisition must be 18 years or older, regardless of gender.
*No ongoing central nervous system and neuromuscular disease.
(2) Those who understand the purpose of this research and can obtain consent in writing regarding participation in this research.
Key exclusion criteria
(1) Subjects with a history or complication of central nervous system, neuromuscular system, or circulatory system disease
(2)Those who have metal in the body (cardiac pacemaker, cochlear implant, etc.)
(3) Pregnant women
(4) Those who have an interest, such as taking lectures taught by the research director or the researcher
(5)Others who are judged to be inappropriate for conducting this research by the principal investigator or co-investigator
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Hikari |
| Middle name | |
| Last name | Kirimoto |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Scoences
Zip code
7348553
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima
TEL
082-257-5445
hkirimoto@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kirimoto |
| Middle name | |
| Last name | Hikari |
Organization
Hiroshima University
Division name
Graduate School of Biomedical and Health Scoences
Zip code
7348553
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima
TEL
082-257-5445
Homepage URL
hkirimoto@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3, Kasumi, Minami-Ku, Hiroshima
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.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
| 2023 | Year | 07 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.researchsquare.com/article/rs-3945088/v1
Number of participants that the trial has enrolled
22
Results
Continuous taVNS significantly increased SAI at 15 min post-stimulation compared to baseline. A positive correlation (Pearson coefficient = 0.563, p = 0.004) was observed between baseline SAI and changes after continuous taVNS.
Results date posted
| 2024 | Year | 04 | Month | 01 | Day |
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
Main results already published
Date of protocol fixation
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 02 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058519
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
