UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019981 |
|---|---|
| Receipt number | R000023071 |
| Scientific Title | Establishment of new methods of fMRI for higher brain function as the pre-surgical evaluation of the neurosurgical procedure |
| Date of disclosure of the study information | 2015/11/29 |
| Last modified on | 2015/11/29 08:16:06 |
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Basic information
Public title
Establishment of new methods of fMRI for higher brain function as the pre-surgical evaluation of the neurosurgical procedure
Acronym
fMRI for higher brain function
Scientific Title
Establishment of new methods of fMRI for higher brain function as the pre-surgical evaluation of the neurosurgical procedure
Scientific Title:Acronym
fMRI for higher brain function
Region
| Japan |
Condition
Condition
epilepsy, brain tumor
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to establish new methods using fMRI for evaluation of higher cognitive function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to justify these examinations with comparison to other examinations and postoperative outcomes: within 3 months after examination, MEG, PET, intraoperative mapping,Neuropsychological test
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
fMRI for higher cognitive function; resting state fMRI, digit-span fMRI, PPT-fMRI, DTI(64axis)
peform once preoperatively
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
patients with brain tumor or epileptic lesion in/around functional dominant areas, who are scheduled for surgery
Key exclusion criteria
1. patients who demonstrate apparent cognitive deficits (MMSE score <24)
2. patients who are not allowed to perform MRI because of body metal or claustrophobia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Maesawa |
Organization
Nagoya University School of Medicine
Division name
Brain and Mind Research Center, Neurosurgery
Zip code
Address
65 Tsurumai, Showa, Nagoya
TEL
052-744-2353
smaesawa@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Maesawa |
Organization
Nagoya University School of Medicine
Division name
Brain and Mind Research Center, Neurosurgery
Zip code
Address
65 Tsurumai, Showa, Nagoya
TEL
052-744-2353
Homepage URL
smaesawa@med.nagoya-u.ac.jp
Sponsor or person
Institute
Brain and Mind Rsearch Center
Institute
Department
Personal name
Funding Source
Organization
Grant in aid for Scientific Research
Organization
Division
Category of Funding Organization
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
| 2015 | Year | 11 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 22 | 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
| 2015 | Year | 11 | Month | 29 | Day |
Last modified on
| 2015 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023071
