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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041808


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name