UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022958
Receipt number R000025992
Scientific Title The elucidation of pathology of brain disease and physiological brain function by means of the clinically recorded electroencephalogram
Date of disclosure of the study information 2016/07/11
Last modified on 2022/05/31 18:26:59

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025992


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name