UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032727
Receipt number 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 07:55:01

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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 or person

Institute

Nara Medical University

Institute

Department

Personal name



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

Value
https://center6.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