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
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
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
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
