UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research of new device for transcranial motor evoked potential monitoring
Title of the study (Brief title)	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	Takenori Akiyama
Organization	School of Medicine Keio University
Division name	Neurosurgery
Address	Shinanomachi 35, Shinjuku, Tokyo
TEL	0353633808
Email	akiyamanor@gmail.com

Public contact
Name of contact person	Ryosuke Tomio
Organization	School of Medicine Keio University
Division name	Neurosurgery
Address	Shinanomachi 35, Shinjuku, Tokyo
TEL	0353633808
Homepage URL
Email	tomy0807@hotmail.com

Sponsor
Institute	School of Medicine Keio University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025263