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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038271
Receipt No. R000043149
Scientific Title The migraine's mechanism and the biomarker of its diagnosis and treatment -a study by wide-band EEG
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/11

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Basic information
Public title The migraine's mechanism and the biomarker of its diagnosis and treatment -a study by wide-band EEG
Acronym The migraine's mechanism and the biomarker of its diagnosis and treatment -a study by wide-band EEG
Scientific Title The migraine's mechanism and the biomarker of its diagnosis and treatment -a study by wide-band EEG
Scientific Title:Acronym The migraine's mechanism and the biomarker of its diagnosis and treatment -a study by wide-band EEG
Region
Japan

Condition
Condition migraine
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Reexamine the electrophysiological characteristics of migraine. Mainly based on the analysis method of wide-band EEG on the scalp EEG.
Basic objectives2 Others
Basic objectives -Others To elucidate the pathology of migraine.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Abnormal findings in conventional EEG and wide-band EEG (Abnormal findings are defined as deviation from normal EEG findings that have been established.).
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
16 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Migraine patients who have undergone electroencephalogram examination according to clinical need and who have given their consent.
Key exclusion criteria Patients who cannot understand/consent.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Akio
Middle name
Last name Ikeda
Organization Kyoto University Graduate School of Medicine
Division name Department of Epilepsy, Movement Disorder and Physiology
Zip code 606-8507
Address 54 Shogoin-Kawahara-cho, Sakyoku Kyoto, 606-8507, JAPAN
TEL 075-751-3318
Email akio@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Kyoko
Middle name
Last name Hosokawa
Organization Kyoto University Graduate School of Medicine
Division name Neurology
Zip code 606-8507
Address 54 Shogoin-Kawahara-cho, Sakyoku Kyoto, 606-8507, JAPAN
TEL 075-751-3772
Homepage URL
Email kyon@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Japan Society For The Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto University Graduate School and Faculty of Medicine Kyoto University Hospital Ethics Committe
Address Yoshidakonoe-cho, Sakyoku Kyoto, 606-8501, JAPAN
Tel 075-753-4680
Email ethcom@kuhp.kyoto-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

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 01 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
2019 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 01 Day
Last follow-up date
2023 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is observational study. We analyze the electroencephalograms of migraine patients that was performed as clinical reason by conventional and wide-band EEG analysis method. To identify abnormal findings, review the electrophysiological characteristics and elucidate the pathology.

Management information
Registered date
2019 Year 10 Month 11 Day
Last modified on
2019 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043149

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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