UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of treatment for neurological dysfunction using Brain-machine interface based on MEG and EEG
Title of the study (Brief title)	Development of treatment using MEG-BMI
Region	Japan

Condition
Condition	Neurological dysfunction
Classification by specialty	Neurology Psychiatry Neurosurgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study develops a treatment for neurological dysfunction using Brain-machine interface based on MEG and EEG signals.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Decoding accuracy of MEG and EEG signals
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patient who can provide individual consent after explanation of this study.
Key exclusion criteria	Patient with severe disabilities to obstruct the experiments
Target sample size	40

Research contact person
Name of lead principal investigator	Yanagisawa Takufumi
Organization	Graduate school of medicine osaka university
Division name	Department of neurosurgery
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3652
Email	tyanagisawa@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person	Yanagisawa Takufumi
Organization	Graduate school of medicine osaka university
Division name	Department of neurosurgery
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-3652
Homepage URL	http://www.nsurg.med.osaka-u.ac.jp/school/research/research.html
Email	tyanagisawa@nsurg.med.osaka-u.ac.jp

Sponsor
Institute	Osaka university
Institute
Department

Funding Source
Organization	Kakenhi
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	大阪大学医学部附属病院（大阪府）

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 12 Month 01 Day
Anticipated trial start date	2013 Year 04 Month 01 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Related information
URL releasing protocol	http://www.nsurg.med.osaka-u.ac.jp/school/research/research.html
Publication of results	Unpublished
URL releasing results	http://www.nsurg.med.osaka-u.ac.jp/school/research/research.html
Results
Other related information	decoding accuracy

Management information
Registered date	2013 Year 03 Month 06 Day
Last modified on	2018 Year 03 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000011922