UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051105 |
|---|---|
| Receipt number | R000058279 |
| Scientific Title | Elucidation of the neural basis of pain-related fear memory extinction using transcranial alternating current stimulation |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2024/01/17 16:22:52 |
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Basic information
Public title
Elucidation of the neural basis of pain-related fear memory extinction using transcranial alternating current stimulation
Acronym
Examining the mechanism underlying the extinction of pain-related fear memories
Scientific Title
Elucidation of the neural basis of pain-related fear memory extinction using transcranial alternating current stimulation
Scientific Title:Acronym
Examining the mechanism underlying the extinction of pain-related fear memories
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to investigate the neural basis underlying the extinction of pain-related fear memory using transcranial alternating current stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
autonomic response
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Condition for modulating brain activity involved extinction of pain-related fear memories
Interventions/Control_2
Condition for modulating brain activity noninvolved extinction of pain-related fear memories
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Participants who have given written consent to participate in this study
Key exclusion criteria
Participants with a history of psychiatric or neurological disorders
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hitomi |
| Middle name | |
| Last name | Ikarashi |
Organization
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-shi, Niigata, Japan
TEL
025-257-4309
hitomi-ikarashi@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Ikarashi |
Organization
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-shi, Niigata, Japan
TEL
025-257-4309
Homepage URL
hitomi-ikarashi@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, 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
| 2023 | Year | 07 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2023 | Year | 05 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058279
| 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 |
