UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049700 |
|---|---|
| Receipt number | R000056611 |
| Scientific Title | Cortical mechanism of transcutaneous vagus nerve stimulation underlying pain alleviation |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2022/12/06 08:40:25 |
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Basic information
Public title
Effect of transcutaneous vagus nerve stimulation on pain perception
Acronym
Effect of transcutaneous vagus nerve stimulation on pain perception
Scientific Title
Cortical mechanism of transcutaneous vagus nerve stimulation underlying pain alleviation
Scientific Title:Acronym
Cortical mechanism of transcutaneous vagus nerve stimulation underlying pain alleviation
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the cortical mechanisms underlying the pain relief using transcutaneous vagus nerve stimulation
Basic objectives2
Others
Basic objectives -Others
To elucidate the cortical mechanisms underlying the pain relief using transcutaneous vagus nerve stimulation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
EEG data
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
transcutaneous vagus nerve stimulation: tVNS
Interventions/Control_2
Sham stimulation
Interventions/Control_3
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy people
Key exclusion criteria
People with disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Michihiro |
| Middle name | |
| Last name | Osumi |
Organization
Kio university
Division name
Neurorehabilitation Research Center
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun
TEL
0745541601
m.ohsumi@kio.ac.jp
Public contact
Name of contact person
| 1st name | Michihiro |
| Middle name | |
| Last name | Osumi |
Organization
Kio university
Division name
Neurorehabilitation Research Center
Zip code
635-0832
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun
TEL
0745541601
Homepage URL
m.ohsumi@kio.ac.jp
Sponsor or person
Institute
Kio university
Institute
Department
Personal name
Funding Source
Organization
Kio university
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
Kio university
Address
4-2-2 Umaminaka, Koryo-cho, Kitakatsuragi-gun
Tel
0745541601
m.ohsumi@kio.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 | 04 | 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
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 12 | Month | 06 | Day |
Last modified on
| 2022 | Year | 12 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056611
