UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002276
Receipt No. R000002785
Scientific Title Developmental research of communication devices based on the brain machine interface using electroencephalograms
Date of disclosure of the study information 2009/08/01
Last modified on 2017/08/06

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Developmental research of communication devices based on the brain machine interface using electroencephalograms
Acronym Communication devices using EEG-based BMI
Scientific Title Developmental research of communication devices based on the brain machine interface using electroencephalograms
Scientific Title:Acronym Communication devices using EEG-based BMI
Region
Japan

Condition
Condition amyotrophic lateral sclerosis
Classification by specialty
Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the efficacy and issues of a communication device using EEG-based BMI by applying it to the patients with severe neuromuscular diseases.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes accuracy of character selection
required time forselecting a character
learning curve
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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Let the patients use the communication devices to select characters on a computer monitor as they intend by recording EEG.
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 The patients with locked-in syndrome or nearly locked-in syndrome
ALS, muscular dystrophy, brain stem stroke, spinal injury
Three months or later after disease name notification
Informed consent is obtained,
The attending doctor has to judge him to be able to attend the study.
Key exclusion criteria not specified
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuk Hirata
Organization Osaka University
Division name Department of Neurosurgery
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3652
Email mhirata@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Hirata
Organization Osaka University
Division name Department of Neurosurgery
Zip code
Address 2-2 Yamadaoka, Suita
TEL 06-6879-3652
Homepage URL
Email mhirata@nsurg.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Japan Brain Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 08 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
2009 Year 07 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2015 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 31 Day
Last modified on
2017 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002785

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.