UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061176 |
|---|---|
| Receipt number | R000070008 |
| Scientific Title | Cognitive training using a Web-based platform for patients with epilepsy: A single-blind randomized controlled trial |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/04/06 22:46:14 |
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Basic information
Public title
The effectiveness of cognitive training using a Web-based platform for people with epilepsy
Acronym
Cognitive training using a Web-based platform for people with epilepsy
Scientific Title
Cognitive training using a Web-based platform for patients with epilepsy: A single-blind randomized controlled trial
Scientific Title:Acronym
Evaluation of the effectiveness of cognitive training using a Web-based platform for epilepsy
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of cognitive training using a web platform on cognitive function in patients with epilepsy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Cognitive Assessment Battery
Key secondary outcomes
Tapping Test; Psychomotor Vigilance Test; Number-Size Congruency Test; Digit Span Test; Time Estimation Test; Eye-Hand Coordination Test; Maze Test; Visual Memory Test; Stroop Test: Eye-Hand Coordination Test; Visual Working Memory Span Test; Naming Test; Multimodal Lexical Memory Test Lexical Memory Test Speed Estimation Test; Distance Estimation Test; Divided Attention Test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Four-week cognitive training program
Interventions/Control_2
Two-week cognitive training program
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Individuals aged 18 to 50
Individuals who own and are able to operate a smartphone or tablet
Individuals who can hear audio clearly on a smartphone or tablet
Individuals with a Wi-Fi connection at home
Individuals who can download the app on their own
Individuals who can communicate via email regarding the study
Key exclusion criteria
Individuals diagnosed with mental disorders, neurological disorders (excluding brain malformations), developmental disorders, or intellectual disabilities
Individuals who have undergone brain resection, deep brain stimulation, or vagus nerve stimulation implantation
Individuals with drug-resistant epilepsy
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Annaka |
Organization
Niigata University of Health and Welfare
Division name
Department of Occupational Therapy
Zip code
950-3198
Address
1398, Shimami-chou, Kita-ku, Niigata
TEL
0252574455
hiroki-annaka@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Annaka |
Organization
Niigata University of Health and Welfare
Division name
Department of Occupational Therapy
Zip code
9503198
Address
1398, Shimami-chou, Kita-ku, Niigata
TEL
0252574455
Homepage URL
hiroki-annaka@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
KAKEN
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyushu University Hospital, Maronie-michi Clinic, National Hospital Organization Nishi-Niigata chuou Hospital, Hokushinetsu Clinic, Wayne State University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare
Address
1398, Shimami-chou, Kita-ku, Niigata
Tel
0252574455
rinri@nuhw.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
| 2026 | Year | 08 | Month | 31 | 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
| 2026 | Year | 04 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 31 | Day |
Last follow-up date
| 2028 | 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 | 04 | Month | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070008
