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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035811
Receipt No. 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

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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
Email 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
Email saatocyk@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

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
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
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
URL(English) https://upload.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
Registered date File name


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