UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018540 |
|---|---|
| Receipt number | R000021456 |
| Scientific Title | Neural activation associated with Future Thinking: fMRI investigation |
| Date of disclosure of the study information | 2015/08/04 |
| Last modified on | 2019/07/03 19:23:14 |
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Basic information
Public title
Neural activation associated with Future Thinking: fMRI investigation
Acronym
FT Study
Scientific Title
Neural activation associated with Future Thinking: fMRI investigation
Scientific Title:Acronym
FT Study
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of this study is to examine functional brain activity on future thinking task in healthy subjects. We will also evaluate cognitive and neuropsychological outcomes.
Basic objectives2
Others
Basic objectives -Others
brain activity
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Bold signal on future thinking task recorded by fMRI
Key secondary outcomes
-Depression symptoms: Beck Depression Inventory, Quick Inventory of Depressive Symptomatology
-Dysfunctional attitude: Dysfunctional Attitude Scale,
-Automatic thoughts: Automatic Thoughts Questionnaire Revised,
QOL: EuroQol
-Resilience: Connor-Davidson Resilience Scale
-Personality trait: Temperament and Personality Questionnaire
-Cognitive function: Word Fluency test, Digit Symbol Substitution test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Subjective response and response time will be examined during future thinking task. (2set, 10 min each)
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Aged >=20 yrs, <=70yrs
2.Subjects who give full consent in the participation of the study.
Key exclusion criteria
1. No history or concurrent DSM-IV Axis I Disorders.
2. No organic brain lesions or major cognitive deficits in a year prior to the screening.
3. No severe or unstable medical illness at screening.
4. Contraindication to MRI (including cardiac pacemaker, claustrophobia)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsuo Nakagawa, MD, PhD |
Organization
Keio University School of Medicine
Division name
Center for Clinical Research
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3235
anakagawa@keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuo Nakagawa, MD, PhD |
Organization
Keio University School of Medicine
Division name
Center for Clinical Research
Zip code
Address
Shinanomachi 35, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3235
Homepage URL
anakagawa@keio.jp
Sponsor or person
Institute
Keio Imaging Study Group
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
慶應義塾大学医学部/慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 04 | 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
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 04 | Day |
Last modified on
| 2019 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021456
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
