UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022293 |
|---|---|
| Receipt number | R000025687 |
| Scientific Title | Clinical application of stereotactic intracranial depth electroencephalogram. |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2018/11/15 20:35:02 |
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Basic information
Public title
Clinical application of stereotactic intracranial depth electroencephalogram.
Acronym
Clinical application of stereotactic intracranial depth electroencephalogram.
Scientific Title
Clinical application of stereotactic intracranial depth electroencephalogram.
Scientific Title:Acronym
Clinical application of stereotactic intracranial depth electroencephalogram.
Region
| Japan |
Condition
Condition
refractory epilepsy
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal a seizure onset zone
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To improve a treatment outcome
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To reveal a seizure onset zone by using stereotactic depth electroencephalogram
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1:Drug resistant refractory epilepsy
2:Surgical removal of epileptic core is needed
3:Hard to detect the seizure onset zone despite consideration of several non-invasive study outcomes
4:informed consent
Key exclusion criteria
1:Having a uncontrollable respiratory or circulatory diseases
2:compromised
3:Cant have a medical examination till 2 years after
4:Having a severe cognitive dysfunction
5:Psychological intolerance of intracranial EEG implantation
6:Afraid of safety due to hyper motor seizure
7:Cant scan MRI
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Susumu Miyamoto |
Organization
Kyoto university hospital
Division name
Neurosurgery
Zip code
Address
54 Shogoin Kawahara-cho Sakyo-ku, Kyoto
TEL
075-751-3653
miy@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Yamao |
Organization
Kyoto university hospital
Division name
Neurosurgery
Zip code
Address
54 Shogoin Kawahara-cho Sakyo-ku, Kyoto
TEL
075-751-3653
Homepage URL
yyamao@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto university hospital
Institute
Department
Personal name
Funding Source
Organization
National institute for Physiological Sciences
Non-linear Oscillology
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 | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | 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 | 05 | Month | 12 | Day |
Last modified on
| 2018 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025687
