UMIN-CTR Clinical Trial

Basic information
Public title	The elucidation of pathology of brain disease and physiological brain function by means of the clinically recorded electroencephalogram
Acronym	The elucidation of pathology of brain disease and physiological brain function by means of the clinically recorded electroencephalogram
Scientific Title	The elucidation of pathology of brain disease and physiological brain function by means of the clinically recorded electroencephalogram
Scientific Title:Acronym	The elucidation of pathology of brain disease and physiological brain function by means of the clinically recorded electroencephalogram
Region	Japan

Condition
Condition	brain disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the pathology of brain disease and the physiological function, and to construct its mathematical model, by analyzing the electroencephalogram recorded with the clinical necessity.
Basic objectives2	Others
Basic objectives -Others	To elucidate the pathology of brain disease and the physiological function.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The results of visual inspection and mathematical analysis of the data of oscillatory activity and paroxysmal activity, such as waveform, amplitude, and phase, recorded with wide-band EEG.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who underwent EEG at Kyoto University Hospital on the clinical purpose
Key exclusion criteria	Patients who disagreed to join this study
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Akio Ikeda
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Epilepsy, Movement Disorders and Physiology
Zip code
Address	54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL	075-751-3771
Email	akio@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Morito Inouchi
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Respiratory Care and Sleep Control Medicine
Zip code
Address	54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto-city
TEL	075-751-3852
Homepage URL
Email	inouchi@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Neurology, Department of Neurology and Department of Epilepsy, Movement Disorders and Physiology
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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	2016 Year 07 Month 11 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	2016 Year 06 Month 27 Day
Date of IRB
Anticipated trial start date	2016 Year 07 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

The main outcome measure is the results of visual inspection and mathematical analysis of the data of oscillatory activity and paroxysmal activity, such as waveform, amplitude, and phase, recorded with wide-band EEG. The concrete methods are visual inspection of DC shifts and HFOs, and mathematical analysis such as Time-frequency analysis, cross frequency coupling, phase locking value, coherence, transfer entropy, and Granger causality test, and so on.

Management information
Registered date	2016 Year 06 Month 30 Day
Last modified on	2022 Year 05 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025992