UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035811 |
|---|---|
| Receipt number | R000040797 |
| Scientific Title | Research of brain functional localization using functional MRI and intracerebral network |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2019/02/08 11:29:20 |
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Basic information
Public title
Research of brain functional localization using functional MRI and intracerebral network
Acronym
Research of brain functional network
Scientific Title
Research of brain functional localization using functional MRI and intracerebral network
Scientific Title:Acronym
Research of brain functional network
Region
| Japan |
Condition
Condition
Brain tumors and epilepsy requiring brain function localization
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of brain surgery using brain functional network
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare the effectiveness of brain surgery using brain functional network before and after surgery
Key secondary outcomes
Motor function, Language function, Higher order function
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
| Maneuver |
Interventions/Control_1
To investigate whether diagnosis using cerebral function department and intracerebral network in epilepsy or brain tumor surgery can improve the treatment effect and neurological findings of postoperative patients.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who need epilepsy or brain tumor surgery, who agreed to participate in this study.
Key exclusion criteria
A person who can not keep their rest, who has metal in the body, and who is Claustrophobia.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kyousuke Kamada |
Organization
Asahikawa Medical University
Division name
Neurosurgery
Zip code
Address
2-1-1, Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2594
kamadyk@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Hiroshima |
Organization
Asahikawa medical college
Division name
Neurosurgery
Zip code
Address
2-1-1, Midorigaoka-higashi, Asahikawa, Hokkaido, Japan
TEL
0166-68-2594
Homepage URL
saatocyk@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Asahikawa Medical University
Organization
Division
Category of Funding Organization
Self funding
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
| 2019 | Year | 03 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 03 | 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
| 2019 | Year | 02 | Month | 08 | Day |
Last modified on
| 2019 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040797
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
