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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012963
Receipt No. R000015155
Scientific Title Investigate the insular function associated with the emotional and interoceptive awareness and using a brain mapping study
Date of disclosure of the study information 2014/02/28
Last modified on 2014/01/26

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Basic information
Public title Investigate the insular function associated with the emotional and interoceptive awareness and using a brain mapping study
Acronym Investigate the insular function associated with the emotional and interoceptive awareness and using a brain mapping study
Scientific Title Investigate the insular function associated with the emotional and interoceptive awareness and using a brain mapping study
Scientific Title:Acronym Investigate the insular function associated with the emotional and interoceptive awareness and using a brain mapping study
Region
Japan

Condition
Condition brain tumor, cavernous angioma
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the insular function associated with the emotional and interoceptive awareness and using a brain mapping study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes emotional awareness, interoception
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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 emotional awareness task, heartbeat perception test
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Aged 20 to 75 years old

2) The patients who are planned to take a surgery for brain tumors or angiomas that are associated with insular areas
Key exclusion criteria No cognitive disorders, aphasia, psychiatric disorders, higher brain dysfunctions
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuya MOTOMURA
Organization Nagoya University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2353
Email kmotomura@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuya MOTOMURA
Organization Nagoya University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL 052-744-2353
Homepage URL
Email kmotomura@med.nagoya-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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
2014 Year 02 Month 28 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
2014 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2014 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
2014 Year 01 Month 26 Day
Last modified on
2014 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015155

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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