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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021606
Receipt No. R000023137
Scientific Title Localization of epileptic focus using auditory stimulation with magnetoencephalography
Date of disclosure of the study information 2016/03/25
Last modified on 2016/03/25

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Basic information
Public title Localization of epileptic focus using auditory stimulation with magnetoencephalography
Acronym auditory stimulation with MEG
Scientific Title Localization of epileptic focus using auditory stimulation with magnetoencephalography
Scientific Title:Acronym auditory stimulation with MEG
Region
Japan

Condition
Condition epilepsy patients
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To detect the lateralization sign using auditory stimulation during MEG.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference of amplitude, latency, phase-locking and source localization of event-related response between subjects.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Forty epilepsy patients and 10 epilepsy patients undertaken electrocorticography and 10 healthy control.
Interventions/Control_2 Auditory stimulation consists of mismatch negativity field and auditory steady-state response.
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria epilepsy patients
Key exclusion criteria post stroke
post trauma accompanied by loss of consciousness
alcoholic or drug abuse within 5 years
pace maker
pregnancy
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shozo Tobimatsu
Organization Kyushu University
Division name Clinical Neurophysiology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka-city
TEL 092-642-5543
Email tobi@neurophy.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teppei Matsubara
Organization Kyushu University
Division name Clinical Neurophysiology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka-city
TEL 092-642-5543
Homepage URL
Email teppeim@med.kyushu-u.ac.jp

Sponsor
Institute Clinical neurophysiology, Kyushu University
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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 03 Month 25 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
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 03 Month 25 Day
Last modified on
2016 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023137

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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