UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019416 |
|---|---|
| Receipt number | R000022435 |
| Scientific Title | Intraoperative mapping and monitoring of electrical connectivity revealed by single pulse electrical stimulation |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2015/11/25 18:34:06 |
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Basic information
Public title
Intraoperative mapping and monitoring of electrical connectivity revealed by single pulse electrical stimulation
Acronym
Intraoperative mapping and monitoring of electrical connectivity
Scientific Title
Intraoperative mapping and monitoring of electrical connectivity revealed by single pulse electrical stimulation
Scientific Title:Acronym
Intraoperative mapping and monitoring of electrical connectivity
Region
| Japan |
Condition
Condition
Any lesion to be resected near the eloquent area.
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of an intraoperative method of mapping and monitoring electrical connectivity.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cortico-cortical evoked potential (intraoperative)
Key secondary outcomes
Subcortico-cortical evoked potential (intraoperative)
MRI (perioperative)
Neurological examination (perioperative)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 7 | years-old | < |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have any lesion to be resected near the functionally important area (s.a. language, motor and higher cognitive function).
Key exclusion criteria
Any patient who doesn't provide consent.
Pregnant patiant.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeharu KUNIEDA |
Organization
Kyoto University Graduate School of Medicine
Division name
Neurosurgery
Zip code
Address
54 Shogoinkawahara-cho Sakyo-ku Kyoto
TEL
+81-75-751-3459
kuny@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeharu KUNIEDA |
Organization
Kyoto University Graduate School of Medicine
Division name
Neurosurgery
Zip code
Address
54 Shogoinkawahara-cho Sakyo-ku Kyoto
TEL
+81-75-751-3459
Homepage URL
kuny@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for the Promotion of Science
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 | 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
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 11 | 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
Study design: Cohort study
Entry criteria: The patients who are to be operated in our hospital and meet the inclusion criteria (written in another part).
Measurement: Intraoperative mapping and monitoring by low frequency electrical stimulation.
Main objective of the study: To assess the clinical benefit of the above electrophysiological examination, the results of the exam are to be compared with the perioperative changes of symptom and those of MR (anatomical and functional) study.
Management information
Registered date
| 2015 | Year | 10 | Month | 20 | Day |
Last modified on
| 2015 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022435
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
