UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054010 |
|---|---|
| Receipt number | R000061660 |
| Scientific Title | Combined visual and brain stimulation for restoration of visual function |
| Date of disclosure of the study information | 2024/03/29 |
| Last modified on | 2024/03/29 16:42:17 |
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Basic information
Public title
Brain stimulation for restoration of visual function
Acronym
Brain stimulation for restoration of visual function
Scientific Title
Combined visual and brain stimulation for restoration of visual function
Scientific Title:Acronym
Brain stimulation for restoration of visual function
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate brain stimulation techniques for activation of the visual cortex in humans
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Amplitudes of visual-evoked potentials immediately after intervention
Key secondary outcomes
Amplitudes of visual-evoked potentials 10, 20, 30, 40, 50, 60, and 70 minutes after intervention
Percentage of error answers of a color contrast detection task immediately after intervention
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
| Maneuver |
Interventions/Control_1
A single session of five-minute repetitive combined stimulation with chromatic light stimulation and transcranial magnetic stimulation over the primary visual cortex
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adult humans who have uncorrected or corrected visual acuity of 0.7 or higher and no disability in daily life
Key exclusion criteria
Person who has intracranial metallic or magnetic pieces, or pacemakers and other implantable medical devices
Person with history of seizures or epilepsy
Person who takes medications, which could lower threshold for seizures (e.g. TCAs, neuroleptic agents)
Person who is suffering from drug abuse or withdrawal symptoms
Person who is pregnant
Person who has uncontrolled medical conditions
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Suzuki |
Organization
Kyorin University
Division name
School of Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
shinya-suzuki@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Suzuki |
Organization
Kyorin University
Division name
School of Medicine
Zip code
181-8611
Address
6-20-2 Shinkawa, Mitaka, Tokyo
TEL
0422-47-5511
Homepage URL
shinya-suzuki@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Kyorin University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Faculty of Medicine Research Ethics Committee, Kyorin University
Address
6-20-2 Shinkawa, Mitaka, Tokyo
Tel
0422-47-5511
rec@ks.kyorin-u.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
| 2024 | Year | 03 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061660
| 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 |
