UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032584
Receipt No. R000037156
Scientific Title Altered neural synchronization to pure tone stimulation in patients with mesial temporal lobe epilepsy: An MEG study
Date of disclosure of the study information 2018/05/14
Last modified on 2018/05/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Altered neural synchronization to pure tone stimulation in patients with mesial temporal lobe epilepsy: An MEG study
Acronym AEF in epilepsy
Scientific Title Altered neural synchronization to pure tone stimulation in patients with mesial temporal lobe epilepsy: An MEG study
Scientific Title:Acronym AEF in epilepsy
Region
Japan

Condition
Condition Epilepsy
Classification by specialty
Neurology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether neural synchronization induced by monaural pure tone stimulation provides useful diagnostic information about epileptic foci in unilateral mTLE patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Group effect of neural synchronization
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 3
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 monaural auditory stimuli: left and right ear to normal control.
Interventions/Control_2 monaural auditory stimuli: left and right ear to left temporal lobe epilepsy.
Interventions/Control_3 monaural auditory stimuli: left and right ear to right temporal lobe epilepsy.
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
20 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria For patient group: Secondary usage of previous study. Patients with temporal lobe epilepsy whose MEG was available from 2012 to 2021.
For control group: Secondary usage fo previous study.
Key exclusion criteria History of severe head trauma, psychiatric diseases, MMSE under 26, alchoholic/drug dependence.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shozo Tobimatsu
Organization Kyushu university
Division name clinical neurophysiology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka-city
TEL 092-642-5543
Email teppei_m2002@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Teppei Matsubara
Organization Kyushu university, Faculty of Medicine
Division name Clinical Neurophysiology
Zip code
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka-city
TEL 092-642-5543
Homepage URL
Email teppei_m2002@yahoo.co.jp

Sponsor
Institute Kyushu university, department of clinical neurophysiology
Institute
Department

Funding Source
Organization MEXT
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
Address
Tel
Email

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
2018 Year 05 Month 14 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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 05 Month 14 Day
Last modified on
2018 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037156

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.