UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057524 |
|---|---|
| Receipt number | R000065706 |
| Scientific Title | Effects of different settings and stimulation modalities of transcutaneous auricular vagus nerve stimulation to the left cymba concha on somatosensory function of the finger |
| Date of disclosure of the study information | 2025/04/07 |
| Last modified on | 2025/04/04 20:33:28 |
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Basic information
Public title
Effects of different settings and stimulation modalities of transcutaneous auricular vagus nerve stimulation to the left cymba concha on somatosensory function of the finger
Acronym
Effects of different settings and stimulation modalities of transcutaneous auricular vagus nerve stimulation to the left cymba concha on somatosensory function of the finger
Scientific Title
Effects of different settings and stimulation modalities of transcutaneous auricular vagus nerve stimulation to the left cymba concha on somatosensory function of the finger
Scientific Title:Acronym
Effects of different settings and stimulation modalities of transcutaneous auricular vagus nerve stimulation to the left cymba concha on somatosensory function of the finger
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Identifying combinations of taVNS stimulus settings and stimulus modalities that improve finger somatosensory function.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Two-point discrimination threshold
Autonomic nerve activity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
8
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Experiment 1
taVNS stimulation period (stimulation time): 15 min
Stimulation condition: 300 microsecond - below pain threshold
The stimulation site: The left cymba conchae
Interventions/Control_2
Experiment 1
taVNS stimulation period (stimulation time): 15 min
Stimulation condition: 500 microsecond - below pain threshold
The stimulation site: The left cymba conchae
Interventions/Control_3
Experiment 1
taVNS stimulation period (stimulation time): 15 min
Stimulation condition: 300 microsecond - midpoint between pain threshold and sensory threshold
The stimulation site: The left cymba conchae
Interventions/Control_4
Experiment 1
taVNS stimulation period (stimulation time): 15 min
Stimulation condition: 500 microsecond - midpoint between pain threshold and sensory threshold
The stimulation site: The left cymba conchae
Interventions/Control_5
Experiment 1
taVNS stimulation period (stimulation time): 15 min
Stimulation condition: Below 500 microsecond-pain threshold with the highest total charge
The stimulation site: The left earlobe
Interventions/Control_6
Experiment 2
taVNS stimulation period (stimulation time): 30 min
Stimulation style: intermittent stimulation
Stimulation condition: the most effective stimulation condition in Experiment 1
The stimulation site: The left cymba conchae
Interventions/Control_7
Experiment 2
taVNS stimulation period (stimulation time): 15 min
Stimulation style: continuous stimulation
Stimulation condition: the most effective stimulation condition in Experiment 1
The stimulation site: The left cymba conchae
Interventions/Control_8
Experiment 2
taVNS stimulation period (stimulation time): 15 min or 30 min
Stimulation mode: intermittent stimulation (30 min) or continuous stimulation (15 min)
Stimulation condition: the most effective stimulation condition in Experiment 1
The stimulation site: The left earlobe
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 27 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We are looking for individuals who are interested in this research and are willing to participate voluntarily. We also invite students and graduate students enrolled in Niigata University of Health and Welfare to join us by e-mail.
Key exclusion criteria
Those with neurological or psychiatric diseases, those taking medication, and those with a history of external ear injury.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kako |
| Middle name | |
| Last name | Tanabe |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
025-257-4445
hwd24002@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Kako |
| Middle name | |
| Last name | Tanabe |
Organization
Graduate School, Niigata University of Health and Welfare
Division name
Institute for Human Movement and Medical Sciences
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
TEL
025-257-4445
Homepage URL
hwd24002@nuhw.ac.jp
Sponsor or person
Institute
Graduate School, Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Graduate School, Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
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
1398 Shimami-cho, Kita-ku, Niigata-city, Niigata, Japan
Tel
025-257-4455
rinri@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
| 2025 | Year | 04 | Month | 07 | 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 | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2027 | 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 | 04 | Month | 04 | Day |
Last modified on
| 2025 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065706
