UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058450 |
|---|---|
| Receipt number | R000066833 |
| Scientific Title | EEG phase-locking phenomenon in blind people avoiding a collision with an energized signal. |
| Date of disclosure of the study information | 2026/07/14 |
| Last modified on | 2025/07/14 03:06:17 |
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Basic information
Public title
EEG phase-locking phenomenon in blind people avoiding a collision with an energized signal.
Acronym
EEG phase-locking phenomenon in blind people avoiding a collision with an energized signal.
Scientific Title
EEG phase-locking phenomenon in blind people avoiding a collision with an energized signal.
Scientific Title:Acronym
EEG phase-locking phenomenon in blind people avoiding a collision with an energized signal.
Region
| Japan |
Condition
Condition
Visual impairment, behavioral control disorder, risk of falls
Classification by specialty
| Ophthalmology | Rehabilitation medicine | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of a novel low-frequency electrical stimulation input method with position-phase effect for conveying information of approaching objects/persons to blind individuals, assessing its impact on collision avoidance success rate and reaction time reduction.
Basic objectives2
Others
Basic objectives -Others
A study of the relationship between energization perception-recognition function and the timing of visual impairment in blind people using a new low-frequency energization stimulus input method based on the positional phase effect in perceiving approaching vehicles and people with energized signals.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Collision avoidance success rate and cognitive reaction time (ms)
Key secondary outcomes
EEG data (alpha wave frequency spike order between AF3-AF4, AF3-PZ, and AF4-PZ, and duration of coherence), subject's subjective evaluation, and stop position accuracy based on video analysis
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Behavior,custom | Other |
Interventions/Control_1
Intervention name: Approach warning by low-frequency current signal using position phase effect Intervention details Two electrodes are applied to symmetrical electrode sites (C4, C5, C6, L4, L5 equivalent sites) on the neck and lumbar skin, two different low-frequency current stimulus waveforms or different energizing patterns with adjusted position phase are applied to the skin, and physiological and behavioral responses based on recognition of the energizing signals arePhysiological and behavioral responses based on the recognition of the electric current signals are measured.
Intervention period 1 day (1 experimental day) Number of interventions Number of interventions: 1 time (up to 10 times per subject) Intervention frequency: 10 consecutive trials, 2-minute pause between each trial Intervention amount: - Current frequency: 20 to 100 Hz - Potential intensity: 5 mA or less - Stimulus duration: up to 30 seconds each trial
Interventions/Control_2
Intervention name: Conventional low-frequency energizing stimulation with a single electrode on the forearm Intervention description: Low-frequency energizing stimulation with a single electrode applied to the medial forearm (conventional method)
Duration of intervention: 1 day (1 experimental day) Number of interventions: 1 time (maximum of 2 trials for each subject) Frequency of intervention: 2 minutes of pause between each trial Amount of intervention: - Electric current frequency: 20 to 100 Hz - Electric potential intensity: 5 mA or less - Stimulation duration: maximum 30 seconds for each trial
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Adults over 20 years old
2. who have read the instructions, understand the purpose of the research, and agree to participate in the research voluntarily
3. who do not have severe balance dysfunction, peripheral neuropathy, or neuropathy due to diabetes
4. who can attend Gunma Paz University or a research collaborating institution
5. who can commute to Gunma Paz University or one of the research collaborating institutions
Key exclusion criteria
1. a person who has an implanted medical device such as a pacemaker
2. a person who has severe peripheral neuropathy or balance dysfunction
3. a person who has serious complications due to diabetes
4. a person who is unable to understand the content of the explanatory document and has difficulty obtaining consent
5. any other person whom the principal investigator determines is inappropriate to participate in this study.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kimura |
Organization
Gunma Paz University
Division name
Department of Rehabilitaion Sciences
Zip code
370-0006
Address
Tonyamachi1-7-1,Takasaki,Gunma, Japan
TEL
080-5015-3631
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
370-0006
Address
1-7-1 Tonyamachi,Takasaki,Gunma
TEL
08050153631
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
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma Paz University
Address
1-7-1 Tonyamchi, Takasaki, Gunma
Tel
027-365-3366
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
群馬パース大学（群馬県）、群馬県社会福祉総合センター（群馬）、日本盲人福祉センター（東京都）、沖縄視覚障害者福祉センター（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
https://kimuakilabo.main.jp/kaken2024-2026-1.html
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 15 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066833
