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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040691
Receipt No. R000046443
Scientific Title Study on anterograde amnesia that appears in frontal lobe lesions
Date of disclosure of the study information 2020/06/08
Last modified on 2020/06/27

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Basic information
Public title Study on anterograde amnesia that appears in frontal lobe lesions
Acronym Study on anterograde amnesia that appears in frontal lobe lesions
Scientific Title Study on anterograde amnesia that appears in frontal lobe lesions
Scientific Title:Acronym Study on anterograde amnesia that appears in frontal lobe lesions
Region
Japan

Condition
Condition anterograde amnesia
Classification by specialty
Hematology and clinical oncology Neurology Neurosurgery
Intensive care medicine Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the characteristics of anterograde amnesia, including reward systems
Basic objectives2 Others
Basic objectives -Others To examine useful treatment methods
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Symptom of anterograde amnesia(Test result of Rivermead Behavioural Memory Test,Mini-Mental State Examinaton,HDS-R and Episode of anterograde amnesia.
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cases with positive amnesia
Key exclusion criteria Cases with difficult or impaired consciousness to correctly respond to language instructions
Target sample size 3

Research contact person
Name of lead principal investigator
1st name Masaharu
Middle name
Last name Maeda
Organization International University of health and welfare
Division name Department of Rehabilitation
Zip code 324-8501
Address 2600-1 Kitakanamaru, Otawara City, Tochigi Prefecture
TEL 0287243016
Email mm@iuhw.ac.jp

Public contact
Name of contact person
1st name Karen
Middle name
Last name Tsushima
Organization International University of health and welfare
Division name Department of Rehabilitation
Zip code 107-8402
Address 4-1-26 Akasaka, Minato-ku, Tokyo
TEL 080-3302-8304
Homepage URL
Email k1573030@yahoo.co.jp

Sponsor
Institute International University of health and welfare
Institute
Department

Funding Source
Organization International University of health and welfare
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 Clinical Trial Review Committee, International University of Health and Welfare
Address Amity Nogizaka 1-24-1 Minami-Aoyama, Minato-ku, Tokyo
Tel 03-5574-3839
Email mm@iuhw.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
2020 Year 06 Month 08 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 Preinitiation
Date of protocol fixation
2020 Year 04 Month 05 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 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

Other
Other related information General information (age, sex, dominant hand, lesion, etc.), neurological symptoms, neuropsychological symptoms, episodes of anterograde amnesia, etc. are collected from medical record information.

Management information
Registered date
2020 Year 06 Month 08 Day
Last modified on
2020 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046443

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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