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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Suspended |
Unique ID issued by UMIN | UMIN000037548 |
Receipt No. | R000042812 |
Scientific Title | Evaluation of cognitive neuroscientific effects of interoceptive training |
Date of disclosure of the study information | 2019/07/30 |
Last modified on | 2020/03/18 |
Basic information | ||
Public title | Evaluation of cognitive neuroscientific effects of interoceptive training | |
Acronym | Interoceptive training | |
Scientific Title | Evaluation of cognitive neuroscientific effects of interoceptive training | |
Scientific Title:Acronym | Interoceptive training | |
Region |
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Condition | ||
Condition | Healthy | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To clarify the effect of the interoceptive training and its brain science characteristics. |
Basic objectives2 | Others |
Basic objectives -Others | NA |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Change ratio of index of interoceptive awareness after 1 week interoceptive training |
Key secondary outcomes | Brain MR Images |
Base | |
Study type | Interventional |
Study design | |
Basic design | Single arm |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Uncontrolled |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 1 | |
Purpose of intervention | Educational,Counseling,Training | |
Type of intervention |
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Interventions/Control_1 | Interoceptive training task for 1 week | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1)18 years old or older
2)A person who has the ability to agree by the person and can obtain informed consent. In the case of a minor, a guardian / support obligation person can check the explanatory document or the public announcement document. 3) At the time of agreement, it is likely to be able to participate in this research schedule which will last for one week |
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Key exclusion criteria | 1) Those who have a serious physical disorder (for example, a bone fracture etc.) that interferes with study participation when participating in the study.
2) Those who receive ongoing treatment for mental and physical diseases at the time of study participation. 3) Those who do not use Japanese as their native language 4) Those who are pregnant 5) Those with metal or electronic equipment in the body and body surface 6) There is a possibility that metal fragments are mixed in the body 7) Those who have tattoos, those with art make 8) Those who engaged in the metal processing industry 9) Claude, dark place phobia In addition to the above, those who the doctor judged as ineligible for survey |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | National Institute of Mental Health,
National Center of Neurology and Psychiatry |
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Division name | Department of Behavioral Medicine | ||||||
Zip code | 187-8553 | ||||||
Address | 4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8553, JAPAN | ||||||
TEL | 042-341-2711 | ||||||
asekiguchi@ncnp.go.jp |
Public contact | |||||||
Name of contact person |
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Organization | National Institute of Mental Health, National Center of Neurology and Psychiatry | ||||||
Division name | Department of Behavioral Medicine | ||||||
Zip code | 187-8553 | ||||||
Address | 4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8553, JAPAN | ||||||
TEL | 042-341-2711 | ||||||
Homepage URL | |||||||
asekiguchi@ncnp.go.jp |
Sponsor | |
Institute | National Center of Neurology and Psychiatry |
Institute | |
Department |
Funding Source | |
Organization | MEXT |
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 | National Center of Neurology and Psychiatry |
Address | 4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8553, JAPAN |
Tel | 042-341-2711 |
ml_rinrijimu@ncnp.go.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 |
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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 | Suspended | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042812 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |