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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035955
Receipt No. R000040948
Scientific Title Study on relationship between accelerated long-term forgetting, functional conectivity and sleep-dependent memory consolidation in epilepsy patients
Date of disclosure of the study information 2019/02/20
Last modified on 2019/02/20

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Basic information
Public title Study on relationship between accelerated long-term forgetting, functional conectivity and sleep-dependent memory consolidation in epilepsy patients
Acronym Study on relationship between accelerated long-term forgetting, functional conectivity and sleep-dependent memory consolidation in epilepsy patients
Scientific Title Study on relationship between accelerated long-term forgetting, functional conectivity and sleep-dependent memory consolidation in epilepsy patients
Scientific Title:Acronym Study on relationship between accelerated long-term forgetting, functional conectivity and sleep-dependent memory consolidation in epilepsy patients
Region
Japan

Condition
Condition epilepsy
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate abnormalities of functional connectivity on brain MRI and sleep-dependent memory consolidatin in epilepsy patients with accelerated long-term forgetting.
Basic objectives2 Others
Basic objectives -Others Exploratory research
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between accelerated long-term forgetting and sleep-dependent memory consolidation,and between accelerated long-term forgetting and the association between prefrontal cortex and hippocampus in fMRI in patients with temporal lobe epilepsy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 epilepsy patients with accelerated long-term forgetting
Interventions/Control_2 epilepsy patients without accelerated long-term forgetting
Interventions/Control_3 control
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
75 years-old >=
Gender Male and Female
Key inclusion criteria focal epilepsy, do not adjust drugs within 1 month before the examination date, Japanese language ability is sufficient
Key exclusion criteria WAIS3 less than 70,aphasia suspected,taking four or more antiepileptic medications,seizures more than two days in the past 4 weeks, a history of mental / neurological disorder, a history of epilepsy surgery, can not get MRI due to metal
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun-ichi Kira
Organization Graduate School of Medical Sciences
Kyushu University
Division name Department of Neurology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, JAPAN
TEL 092-642-5340
Email kira@neuro.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taira Uehara
Organization Graduate School of Medical Sciences Kyushu University
Division name Department of Neurophysiology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, JAPAN
TEL 092-642-5340
Homepage URL
Email tuehara@neuro.med.kyushu-u.ac.jp

Sponsor
Institute Graduate School of Medical Sciences
Kyushu University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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
Address
Tel
Email

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
2019 Year 02 Month 20 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
2019 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 01 Day
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
2019 Year 02 Month 20 Day
Last modified on
2019 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040948

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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