![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000030928 |
Receipt No. | R000035325 |
Scientific Title | Effect of attention bias modification on event-related potentials in patients with irritable bowel syndrome. |
Date of disclosure of the study information | 2018/01/22 |
Last modified on | 2018/01/22 |
Basic information | ||
Public title | Effect of attention bias modification on event-related potentials in patients with irritable bowel syndrome. | |
Acronym | Effect of ABM on ERP in IBS. | |
Scientific Title | Effect of attention bias modification on event-related potentials in patients with irritable bowel syndrome. | |
Scientific Title:Acronym | Effect of ABM on ERP in IBS. | |
Region |
|
Condition | ||||
Condition | irritable bowel syndrome | |||
Classification by specialty |
|
|||
Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Hypothesis of this study, abnormality of attention of IBS that the event-related potential as an indicator will be normalized after the ABM implementation. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | event related potential |
Key secondary outcomes |
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 |
|
|
Interventions/Control_1 | attention bias modification | |
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 |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | irritable bowel syndrome | |||
Key exclusion criteria | a)history and current suspicion of psychosis disorder; (b) a serious psychiatric condition such as suicidal ideation, self-harm behavior, or severe dissociation. | |||
Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Nagasaki University | ||||||
Division name | Graduate School of Education | ||||||
Zip code | |||||||
Address | 1-14, Bunkyo, Nagasaki | ||||||
TEL | +81-95-819-2397 | ||||||
jtayama@nagasaki-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Nagasaki University | ||||||
Division name | Graduate School of Education | ||||||
Zip code | |||||||
Address | 1-14, Bunkyo, Nagasaki | ||||||
TEL | +81-95-819-2397 | ||||||
Homepage URL | |||||||
jtayama@nagasaki-u.ac.jp |
Sponsor | |
Institute | Graduate School of Education, Nagasaki University |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
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 |
|
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 | As a result of the group comparison at the time of P100 latency at P4, the difference of the latency of the IBS group and the non-IBS group was seen in session 1, it was not seen in session 5(last session). In conclusion, by the practice of the ABM to the IBS, normalize brain function associated with the attention was found. |
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 | Completed | ||||||
Date of protocol fixation |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035325 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |