UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036306 |
|---|---|
| Receipt number | R000041367 |
| Scientific Title | Development of novel communication tools using brain signals |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2024/03/30 11:35:46 |
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Basic information
Public title
Development of novel communication tools using brain signals
Acronym
Novel communication tools using brain signals
Scientific Title
Development of novel communication tools using brain signals
Scientific Title:Acronym
Novel communication tools using brain signals
Region
| Japan |
Condition
Condition
Normal adult and child, Amyotrophic lateral sclerosis (ALS)
Classification by specialty
| Neurology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish novel communication tools using brain signals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of brain machine interface
Key secondary outcomes
Brain activity(EEG, fMRI), movements(EMG, reaction time, etc.), Psychological evaluation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
existence of attention to sensory stimulus
Interventions/Control_2
kind of sense
Interventions/Control_3
stimulus location and strength
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Normal adults, physically handicapped adults, and normal children (above 6 years old) who actively participate with written informed consent of the participants or their proxies.
Key exclusion criteria
persons with heavily secondary disability
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toshimitsu |
| Middle name | |
| Last name | Takahashi |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Physiology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-87-2126
tositaka@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Toshimitsu |
| Middle name | |
| Last name | Takahashi |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Physiology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-87-2126
Homepage URL
tositaka@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Dokkyo Medical University School of Medicine
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
Tel
0282-87- 2474
kenkyu@dokkyomed.ac.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
| 2019 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2019 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041367
| 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 |
