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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032727
Receipt No. R000037320
Scientific Title Bite injuries caused by transcranial electrical stimulation motor-evoked potentials monitoring: incidence, associated factors.
Date of disclosure of the study information 2018/06/01
Last modified on 2019/11/26

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Basic information
Public title Bite injuries caused by transcranial electrical stimulation motor-evoked potentials monitoring: incidence, associated factors.
Acronym Bite injuries caused by transcranial electrical stimulation motor-evoked potentials monitoring
Scientific Title Bite injuries caused by transcranial electrical stimulation motor-evoked potentials monitoring: incidence, associated factors.
Scientific Title:Acronym Bite injuries caused by transcranial electrical stimulation motor-evoked potentials monitoring
Region
Japan

Condition
Condition the patients underwent TES-MEP monitorings
Classification by specialty
Orthopedics Anesthesiology Neurosurgery
Emergency medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 incidence and associated factors
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes incidence and associated factors
Key secondary outcomes sensitivity and specificity

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
12 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients undergoing TES-MEP monitoring during elective surgeries at Nara Medical University
Key exclusion criteria emergency surgery
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name ida
Middle name
Last name Mitsuru
Organization Nara Medical University
Division name Anesthesiology
Zip code 6348521
Address 840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL 0744-22-3051
Email drjkawa@gmail.com

Public contact
Name of contact person
1st name Mitsuru
Middle name
Last name Ida
Organization Nara Medical University
Division name Anesthesiology
Zip code 6348521
Address 840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL 0744-22-3051
Homepage URL
Email nwnh0131@yahoo.co.jp

Sponsor
Institute Nara Medical University
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 Nara Medical University
Address Shijo-machi 840
Tel 0744298902
Email nwnh0131@yahoo.co.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
2018 Year 06 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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 25 Day
Date of IRB
2018 Year 05 Month 19 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2023 Year 06 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2018 Year 05 Month 25 Day
Last modified on
2019 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037320

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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