UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036577 |
|---|---|
| Receipt number | R000041636 |
| Scientific Title | Facial emotion recognition in patients with temporal lobe epilepsy: brain functional and morphological correlates |
| Date of disclosure of the study information | 2019/04/23 |
| Last modified on | 2020/04/18 10:43:54 |
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Basic information
Public title
Facial emotion recognition in patients with temporal lobe epilepsy: brain functional and morphological correlates
Acronym
Facial emotion recognition in patients with temporal lobe epilepsy: brain functional and morphological correlates
Scientific Title
Facial emotion recognition in patients with temporal lobe epilepsy: brain functional and morphological correlates
Scientific Title:Acronym
Facial emotion recognition in patients with temporal lobe epilepsy: brain functional and morphological correlates
Region
| Japan |
Condition
Condition
Temporal Lobe Epilepsy
Classification by specialty
| Neurology | Psychiatry | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the alteration of magnetoencephalographic (MEG) responses to emotional faces (M170) and associated brain structures 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 amplitude and latency differences of emotional face evoked M170 between healthy control and temporal lobe epilepsy
Key secondary outcomes
The relationship between performance of facial emotion recognition and volume changes in amygdala, hippocampus and cerebral cortices
The relationship between the amplitude and latency of emotional face evoked M170 and volume changes in amygdala, hippocampus and cerebral cortices
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Facial emotion recognition task
Magnetoencephalography (MEG)
Brain MRI
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 or highly suspected temporal lobe epilepsy
2. Patients are evaluated by board certified epileptologists. Focal 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. No visual disability
4. Right handed
5. Fluent in written and spoken Japanese
Key exclusion criteria
1. History of epilepsy surgery
2. Neurological and psychiatric comorbidities
3. Any contraindications to MRI or MEG
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Jun-ichi |
| Middle name | |
| Last name | Kira |
Organization
Graduate School of Medicine, Kyushu University
Division name
Department of Neurology, Neurological Institute
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
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 Medicine, Kyushu University
Division name
Department of Clinical Neurophysiology, Neurological Institute
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
TEL
092-642-5340
Homepage URL
tuehara@neuro.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Neurological Institute,
Graduate School of Medicine,
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
Section of IRB & Ethics Committee Administration, Academic Research Support Division, Kyushu University Hospital
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
Tel
092-642-5082
byskenkyu@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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 23 | 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
4
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
Terminated
Date of protocol fixation
| 2019 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2020 | 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 | 04 | Month | 23 | Day |
Last modified on
| 2020 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041636
