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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029570
Receipt No. R000033755
Scientific Title Investigation for clinical factors contributing to accelerated long-term forgetting in epilepsy patients
Date of disclosure of the study information 2017/10/26
Last modified on 2018/04/17

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Basic information
Public title Investigation for clinical factors contributing to accelerated long-term forgetting in epilepsy patients
Acronym Contributing factors for accelerated long-term forgetting in epilepsy
Scientific Title Investigation for clinical factors contributing to accelerated long-term forgetting in epilepsy patients
Scientific Title:Acronym Contributing factors for accelerated long-term forgetting in epilepsy
Region
Japan

Condition
Condition Localization Related Epilepsy
Classification by specialty
Neurology Psychiatry Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the impact of interictal epileptic discharges and morphometric changes of brain on accelerated long-term forgetting(ALF) in patients with temporal lobe epilepsy
Basic objectives2 Others
Basic objectives -Others Pathological mechanism
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The relationship between ALF and interictal epileptic discharges(IEDs) in non-REM sleep, or temporal lobe lesions in patients with temporal lobe epilepsy
Key secondary outcomes Prevalence of ALF in temporal lobe epilepsy and extra-temporal lobe epilepsy

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment Other
Interventions/Control_1 Neuropsychological exams(day1 & day7)
Brain MRI
Sleep EEG
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients with clinically diagnosed localization related epilepsy
2. Patients are evaluated by board certified epileptologists. Localization related epilepsy is defined as follows;
(A) at least two unprovoked seizures occurring greater than 24 hours apart
(B) localization is evidenced by at least one of the following examinations; EEG recording, MRI, FDG-PET, SPECT or MEG
(C) ictal semiology is compatible to the lesions detected by examinations
3. Fluent in written and spoken Japanese
Key exclusion criteria 1. Estimated full scale IQ <70
2. Suspected aphasia with a screening test
3. History of epilepsy surgery
4. Neurological and psychiatric comorbidities
5. Any contraindications to MRI
6. History of residency in specific cities(Yanagawa city, Yukuhashi city and Beppu city) where movies for original neuropsychological examination were filmed
Target sample size 155

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Kira
Organization Graduate School of Medicine,
Kyushu University
Division name Department of Neurology, Neurological Institute
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka city
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 Medicine, Kyushu University
Division name Department of Clinical Neurophysiology, Neurological Institute
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka city
TEL 092-642-5340
Homepage URL
Email tuehara@neuro.med.kyushu-u.ac.jp

Sponsor
Institute Department of Neurology, Neurological Institute,
Graduate School of Medicine,
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 Fukuoka Sanno Hospital
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 九州大学病院(福岡県)、福岡山王病院(福岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 26 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 Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 20 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 26 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
2017 Year 10 Month 16 Day
Last modified on
2018 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033755

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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