UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040691
Receipt number 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 17:52:39

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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 or person

Institute

International University of health and welfare

Institute

Department

Personal name



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

Value
https://center6.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