UMIN-CTR Clinical Trial

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
Email	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
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
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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041636