UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061060 |
|---|---|
| Receipt number | R000069867 |
| Scientific Title | EEG Patterns During Morse-Code Electrotactile Stimulation in Individuals with Blindness |
| Date of disclosure of the study information | 2026/03/26 |
| Last modified on | 2026/03/26 17:59:57 |
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Basic information
Public title
EEG Phase Synchronization Associated with Electrotactile Morse-Code Collision Avoidance in People with Blindness
Acronym
EEG with Electrotactile Morse-Code
Scientific Title
EEG Patterns During Morse-Code Electrotactile Stimulation in Individuals with Blindness
Scientific Title:Acronym
EEG with Electrotactile Morse-Code
Region
| Japan |
Condition
Condition
Individuals with Blindness
Classification by specialty
| Ophthalmology | Rehabilitation medicine | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate task success in an electrotactile Morse code collision-avoidance task in blind participants, to determine whether age at vision loss predicts success in adventitiously blind individuals, and to identify EEG connectivity patterns associated with successful versus failed task performance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Recognition success rate within 0.2 seconds
Key secondary outcomes
EEG activity during successful recognition(wPLI/MSC)
EEG activity during failed recognition(wPLI/MSC)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Participants performed continuous lateral head rotation. When the onboard computer vision system detected an approaching person within the frontal camera field of view, the corresponding Morse code signal was delivered electrotactically to the skin surface. Participants were instructed to cease head rotation and point their index finger toward the midline upon perceiving and identifying the delivered Morse code character.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Complete blindness with no light perception
Absence of any pharmacological treatment for neurological conditions
Key exclusion criteria
Any residual light perception or form vision
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kimura |
Organization
Gunma Paz University
Division name
Graduate School of Health Sciences
Zip code
370-0006
Address
Tonyamachi1-7-1,Takasaki,Gunma
TEL
0273653366
a-kimura@paz.ac.jp
Public contact
Name of contact person
| 1st name | AKIRA |
| Middle name | |
| Last name | Kimura |
Organization
Gunma Paz University
Division name
Department of Rehabilitation Sciences
Zip code
3700006
Address
1-7-1 Tonyamachi,Takasaki,Gunma
TEL
0273653366
Homepage URL
https://kimuakilabo.main.jp/kaken2024-2026-1.html
kimuaki@nifty.com
Sponsor or person
Institute
Gunma Paz University
Institute
Department
Personal name
Akira Kimura
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Okinawa Prefectural Okinawa School for the Blind
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Paz University IRB
Address
1-7-1 Tonyamchi, Takasaki, Gunma
Tel
0273653366
kimuaki@nifty.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
群馬県
Institutions
Institutions
沖縄県立沖縄盲学校
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2026 | Year | 03 | Month | 26 | Day |
Last modified on
| 2026 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069867
