UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037016 |
|---|---|
| Receipt number | R000041808 |
| Scientific Title | Investigation for the effect of interictal epileptic discharges on cognitive function in epilepsy patients |
| Date of disclosure of the study information | 2019/06/10 |
| Last modified on | 2019/06/10 15:34:28 |
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Basic information
Public title
Investigation for the effect of interictal epileptic discharges on cognitive function in epilepsy patients
Acronym
The effect of interictal epileptic discharges on cognitive function in epilepsy patients
Scientific Title
Investigation for the effect of interictal epileptic discharges on cognitive function in epilepsy patients
Scientific Title:Acronym
The effect of interictal epileptic discharges on cognitive function in epilepsy patients
Region
| Japan |
Condition
Condition
Localization related epilepsy
Classification by specialty
| Neurology | Psychiatry | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyze relation between interictal epileptic discharges and sleep-dependent enhancement of motor sequence learning in epilepsy patients
Basic objectives2
Others
Basic objectives -Others
Pathological mechanism
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Analyze relation between interictal epileptic discharges and sleep-dependent enhancement of motor sequence learning in epilepsy patients
Key secondary outcomes
Analyze differences of sleep-dependent enhancement of motor sequence learning between epilepsy patients and healthy subjects
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
Educational,Counseling,Training
Type of intervention
| Device,equipment | Maneuver | Other |
Interventions/Control_1
Motor sequence learning (day1 & day7)
Sleep EEG (patients group only, day1 & day7)
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[Patient group] Localization related epilepsy patients, patients who are going to undergo log-term video-EEG monitoring, patients who have sufficient ability to understand Japanese
[Control group] subjects who have sufficient ability to understand Japanese
Key exclusion criteria
[Patient group] patients who have disability of upper limb, patients who have history of neurological or psychiatric disease expect for epilepsy, patients who are professional piano player and professional typewriter, patients who shift-work at night
[Control group] subjects who have disability of upper limb, subjects who have history of neurological or psychiatric disease, subjects who are professional piano player and professional typewriter, subjects who shift-work at night
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Jun-ichi |
| Middle name | |
| Last name | Kira |
Organization
Graduate School of Medicine, Kyushu University
Division name
Department of Neurology, Neurological Institute
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
TEL
092-642-5340
kira@neuro.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Taira |
| Middle name | |
| Last name | Uehara |
Organization
Graduate School of Medicine, Kyushu University
Division name
Department of Clinical Neurophysiology, Neurological Institute
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
TEL
092-642-5340
Homepage URL
tuehara@neuro.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Neurological Institute, Graduate School of Medicine, Kyushu 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
Kyushu University Certified Institutional Reviews Board for Clinical Trials
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
Tel
092-642-5082
byskenkyu@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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 10 | 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
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2019 | Year | 06 | Month | 10 | Day |
Last modified on
| 2019 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041808
