UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021905 |
|---|---|
| Receipt number | R000025263 |
| Scientific Title | Research of new device for transcranial motor evoked potential monitoring |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2017/07/06 17:28:30 |
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Basic information
Public title
Research of new device for transcranial motor evoked potential monitoring
Acronym
Research of new device for transcranial motor evoked potential monitoring
Scientific Title
Research of new device for transcranial motor evoked potential monitoring
Scientific Title:Acronym
Research of new device for transcranial motor evoked potential monitoring
Region
| Japan |
Condition
Condition
Patients who needs intraoperative MEP monitoring during neurosurgery
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An aim of this study is to develop an appropriate stimulate electrode for improvement of intraoperative transcranial motor evoked potential monitoring.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We compare threshold (mA) of MEP at abductor pollicis (APB) muscle between using new stimulating electrode and conventional product.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Using new stimulating electrode insetead of conventional product for transcranial MEP monitoring.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A patient who needs intraoperative MEP monitoring for motor function preservation at neurosurgery.
Key exclusion criteria
A patient who have motor deficit and/or compression to the pyramidal tract.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takenori Akiyama |
Organization
School of Medicine Keio University
Division name
Neurosurgery
Zip code
Address
Shinanomachi 35, Shinjuku, Tokyo
TEL
0353633808
akiyamanor@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryosuke Tomio |
Organization
School of Medicine Keio University
Division name
Neurosurgery
Zip code
Address
Shinanomachi 35, Shinjuku, Tokyo
TEL
0353633808
Homepage URL
tomy0807@hotmail.com
Sponsor or person
Institute
School of Medicine Keio University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 05 | 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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 25 | 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
| 2016 | Year | 04 | Month | 14 | Day |
Last modified on
| 2017 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025263
| 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 |
