UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021606 |
|---|---|
| Receipt number | 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 | 2020/03/28 11:20:21 |
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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 | Shozo |
| Middle name | |
| Last name | Tobimatsu |
Organization
Kyushu University
Division name
Clinical Neurophysiology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-city
TEL
092-642-5543
tobi@neurophy.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Matsubara |
Organization
Kyushu University
Division name
Clinical Neurophysiology
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-city
TEL
092-642-5543
Homepage URL
teppeim@med.kyushu-u.ac.jp
Sponsor or person
Institute
Clinical neurophysiology, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
IRB Kyushu University
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka-city
Tel
092-642-5082
byskenkyu@jimu.kyushu-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
| 2016 | Year | 03 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
46
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
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
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
| 2020 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023137
