UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022581 |
|---|---|
| Receipt number | R000026025 |
| Scientific Title | Clinical application of MR image toward the implanting intracranial electrodes patients |
| Date of disclosure of the study information | 2016/06/03 |
| Last modified on | 2022/12/07 09:43:08 |
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Basic information
Public title
Clinical application of MR image toward the implanting intracranial electrodes patients
Acronym
Clinical application of MR image toward the implanting intracranial electrodes patients
Scientific Title
Clinical application of MR image toward the implanting intracranial electrodes patients
Scientific Title:Acronym
Clinical application of MR image toward the implanting intracranial electrodes patients
Region
| Japan |
Condition
Condition
refractory epilepsy
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
reveal the epilepsy network and improve on the surgery outcome
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of electrodes positional information
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1:Refractory epilepsy even after being treated with several appropriate drugs.
2:Surgical eligibility of resecting epileptic core
3:Despite multiple results of the non-invasive investigations, hard to detect the epileptic core
4:Can obtain informed consent
5:Can scan MR imaging stable before and after surgery
Key exclusion criteria
1:Having a uncontrollable respiratory or circulatory disease
2:Compromised
3:Can 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:Can't scan MRI
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Miyamoto |
Organization
Kyoto University Hospital
Division name
Neurosurgery
Zip code
606-8507
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 | Taku |
| Middle name | |
| Last name | Inada |
Organization
Kyoto University Hospital
Division name
Neurosurgery
Zip code
606-8507
Address
54 Shogoin Kawahara-cho Sakyo-ku, Kyoto
TEL
075-751-3653
Homepage URL
inada@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
National institute for Physiological Science
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
Kyoto University Hospital
Address
54 Shogoin Kawahara-cho Sakyo-ku, Kyoto
Tel
075-751-3653
inada@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
| 2016 | Year | 06 | Month | 03 | 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 | 06 | Month | 03 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Obtain the positional information of electrodes
Management information
Registered date
| 2016 | Year | 06 | Month | 02 | Day |
Last modified on
| 2022 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026025
