UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038271 |
|---|---|
| Receipt number | 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 | 2024/10/15 15:47:12 |
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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
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
kyon@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.clinph.2024.07.020
Number of participants that the trial has enrolled
145
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
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 11 | Day |
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
| 2024 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043149
