UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053910 |
|---|---|
| Receipt number | R000061218 |
| Scientific Title | Research on the Pathophysiology of Memory Consolidation Disorders in Focal Epilepsy |
| Date of disclosure of the study information | 2024/03/19 |
| Last modified on | 2024/03/19 23:56:07 |
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Basic information
Public title
Research on the Pathophysiology of Memory Consolidation Disorders in Focal Epilepsy
Acronym
Research on the Pathophysiology of Memory Consolidation Disorders in Focal Epilepsy
Scientific Title
Research on the Pathophysiology of Memory Consolidation Disorders in Focal Epilepsy
Scientific Title:Acronym
Research on the Pathophysiology of Memory Consolidation Disorders in Focal Epilepsy
Region
| Japan |
Condition
Condition
Focal epilepsy
Classification by specialty
| Neurology | Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarifying the involvement of epileptiform discharges in memory disorders in patients with epilepsy.
Basic objectives2
Others
Basic objectives -Others
Clarifying the Effects of Anti-Epileptic Drugs on Memory in patients with epilepsy.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of Targeted Memory Reactivation on Memory Consolidation in Patients with Epilepsy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Patients with focal epilepsy
Interventions/Control_2
Healthy Control
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
| 16 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
<Patient Group>
1. Patients admitted for long-term video EEG monitoring at a department of neurology or neurosurgery.
2. Patients who fully understand this research plan and are capable of giving consent themselves (and by a proxy if necessary).
3. Patients who are at least 16 years old at the time of consent.
<Control Group>
1. Individuals who are physically and mentally healthy.
2. Individuals who fully understand this research plan and are capable of giving consent on their own.
3. Individuals who are at least 18 years old but younger than 60 at the time of consent.
4. Individuals who have sufficient proficiency in Japanese.
Key exclusion criteria
<Patient Group>
1. Patients with intellectual disabilities that prevent the administration of neuropsychological tests.
2. Patients with hearing impairments (diagnosed by a physician).
3. Patients whose EEG recordings are inadequate due to complications such as bleeding.
4. Patients whom researchers deem inappropriate for the study for other reasons.
<Control Group>
1. Individuals with intellectual disabilities.
2. Individuals who have been diagnosed with neurological or psychiatric disorders in the past.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Shigeto |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Division of Medical Technology, Department of Health Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5340
shinkein@neuro.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiko |
| Middle name | |
| Last name | Mukaino |
Organization
Graduate School of Medical Sciences, Kyushu University
Division name
Department of Neurology
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5340
Homepage URL
shinkein@neuro.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
The Clinical Research Promotion Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Hospital, Administration Department, Research Support Division, Ethics Review Section
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5082
byclinicaltrials@jimu.kyushu-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
九州大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 02 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 29 | 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
| 2024 | Year | 03 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061218
| 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 |
