UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002276 |
|---|---|
| Receipt number | 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 | 2022/02/04 14:36:19 |
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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 | Masayuki |
| Middle name | |
| Last name | Hirata |
Organization
Osaka University
Division name
Department of Neurosurgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3652
mhirata@nsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Hirata |
Organization
Osaka University
Division name
Department of Neurosurgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita
TEL
06-6879-3652
Homepage URL
mhirata@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
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
Osaka General Medical Center
Address
Sumiyoshi, Osaka
Tel
06-6692-1201
unknown
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
https://www.tandfonline.com/doi/pdf/10.1080/2326263X.2015.1132080
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/pdf/10.1080/2326263X.2015.1132080
Number of participants that the trial has enrolled
24
Results
Patients who had a robust P300 response over the occipital area showed a higher success rate in the P300-BCI compared with patients who had a large P300 response over the fronto-central area.
Results date posted
| 2022 | Year | 02 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
healthy volunteers
Participant flow
IC and experiments
Adverse events
none
Outcome measures
P300 response
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
| 2009 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | 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
| 2022 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002785
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
