UMIN-CTR Clinical Trial

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
Email	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
Email	tuehara@neuro.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Neurology, Neurological Institute, Graduate School of Medicine, Kyushu University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041808