UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043651 |
|---|---|
| Receipt number | R000049851 |
| Scientific Title | fMRI study on body image recognition |
| Date of disclosure of the study information | 2021/03/17 |
| Last modified on | 2025/09/30 14:34:59 |
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Basic information
Public title
fMRI study on body image recognition
Acronym
fMRI study on body image recognition
Scientific Title
fMRI study on body image recognition
Scientific Title:Acronym
fMRI study on body image recognition
Region
| Japan |
Condition
Condition
Anorexia nervosa
Classification by specialty
| Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We'll investigate brain activities related to body image recognition of people with anorexia.
Basic objectives2
Others
Basic objectives -Others
Brain imaging
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brain activity while looking at one's own body image.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
We'll recruit people with anorexia who meet DSM-5 criteria.
Key exclusion criteria
Male.
A person who has metal in his or her body, who has strong myopia, who is during pregnancy, who has claustrophobia, who is left-handed.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Motoaki |
| Middle name | |
| Last name | Sugiura |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer, Dept. Human Brain Science
Zip code
980-8575
Address
3F International Center for Smart Ageing Research, Seiryo-machi 4-1, Aoba-ku Sendai, Miyagi
TEL
022-717-8563
motoaki.sugiura.d6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Hamamoto |
Organization
Tohoku University
Division name
Institute of Development, Aging and Cancer, Dept. Human Brain Science
Zip code
980-8575
Address
3F International Center for Smart Ageing Research, Seiryo-machi 4-1, Aoba-ku Sendai, Miyagi
TEL
022-717-8563
Homepage URL
yumi.hamamoto.q2@dc.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Research Ethics Committee, School of Medicine, Tohoku University
Address
Seiryo-machi, 2-1, Sendai
Tel
022-717-8007
med-kenkyo@grp.tohoku.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
| 2021 | Year | 03 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0166432823000670?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0166432823000670?via%3Dihub
Number of participants that the trial has enrolled
41
Results
Perceived disturbance showed a positive correlation with activity in the right anterior cingulate cortex, and functional connectivity from the left extrastriate body area showed a positive correlation with the left anterior insular cortex. Conversely, affective disturbance showed a positive correlation with activity in the right temporo-parietal junction and a negative correlation with functional connectivity between the left extrastriate body area and the precuneus.
Results date posted
| 2025 | Year | 09 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirty-six non-diagnostic right-handed female participants in the undergraduate and graduate schools of Tohoku University were recruited for this study. Participants had no history of psychiatric disorders, which were evaluated based on participants' self-reports. The exclusion criteria were male sex, left-handedness, a history of psychiatric disorders, pregnancy, and the presence of metal implants in the body.
Participant flow
We recruited 41 participants, but five participants were excluded because of poor behavioral performance.
Adverse events
None
Outcome measures
Neural responses
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 11 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 01 | Month | 04 | Day |
Other
Other related information
We'll take participants' pictures, then we'll change them into silhouette images. In the MRI scanner, participants will look at the silhouette images distorted in width. Participants will judge if the image is (1) more overweight than themselves (2) more overweight than ideal body image. We'll investigate the brain activities while participants are looking at their silhouette.
Management information
Registered date
| 2021 | Year | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049851
