UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035955 |
|---|---|
| Receipt number | 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 | 2020/02/21 09:54:39 |
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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 80,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 | Jun-ichi |
| Middle name | |
| Last name | Kira |
Organization
Graduate School of Medical Sciences
Kyushu University
Division name
Department of Neurology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, JAPAN
TEL
092-642-5340
kira@neuro.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Taira |
| Middle name | |
| Last name | Uehara |
Organization
Graduate School of Medical Sciences Kyushu University
Division name
Department of Neurophysiology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, JAPAN
TEL
092-642-5340
Homepage URL
tuehara@neuro.med.kyushu-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences
Kyushu University
Institute
Department
Personal name
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
Kyushu University IRB
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, JAPAN
Tel
092-642-5774
byshinsa@jimu.kyushu-u.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
| 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
| 2021 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
