UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037622 |
|---|---|
| Receipt number | R000042896 |
| Scientific Title | Investigate the autonomic nervous system function associated with the insular cortex or the orbitofrontal cortex using awake brain mapping |
| Date of disclosure of the study information | 2019/08/07 |
| Last modified on | 2019/08/07 16:23:10 |
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Basic information
Public title
Investigate the autonomic nervous system function associated with the insular cortex or the orbitofrontal cortex using awake brain mapping
Acronym
Investigate the autonomic nervous system function associated with the insular cortex or the orbitofrontal cortex using awake brain mapping
Scientific Title
Investigate the autonomic nervous system function associated with the insular cortex or the orbitofrontal cortex using awake brain mapping
Scientific Title:Acronym
Investigate the autonomic nervous system function associated with the insular cortex or the orbitofrontal cortex using awake brain mapping
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 autonomic nervous system function associated with the insular cortex or the orbitofrontal cortex using awake brain mapping.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
autonomic nervous system function
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
The record of electrocardiogram record of electrocardiogram, heart rate and blood pressure, 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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Aged 18 to 75 years old
2) The patients who are planned to take a surgery for brain tumors or angiomas that are associated with insular cortex or orbitofrontal cortex
Key exclusion criteria
No cognitive disorders, aphasia, psychiatric disorders, higher brain dysfunctions
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kazuya |
| Middle name | |
| Last name | Motomura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2353
kmotomura@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Motomura |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2353
Homepage URL
kmotomura@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Nagoya University Graduate School of Medicine
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
The institutional review board at Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel
052-744-2061
ethics@med.nagoya-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
| 2019 | Year | 08 | Month | 07 | 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 | 08 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 07 | Day |
Last modified on
| 2019 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042896
