UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024493
Receipt number R000028191
Scientific Title How EEG oscillations can predict MEP amplitudes?
Date of disclosure of the study information 2016/10/20
Last modified on 2019/10/28 14:43:12

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Basic information

Public title

How EEG oscillations can predict MEP amplitudes?

Acronym

MEPs and EEGs

Scientific Title

How EEG oscillations can predict MEP amplitudes?

Scientific Title:Acronym

MEPs and EEGs

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Exploratory experiments to reveal brain function

Basic objectives2

Others

Basic objectives -Others

To reveal the EEG characteristics to determine MEP amplitudes

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

EEG power difference

Key secondary outcomes

EEG phase difference


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Transcranial magnetic stimulation
stimulus intensity
coil size
coil direction
eyes open/closed
real time analysis of EEG

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

20 years-old <=

Age-upper limit

65 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy adults

Key exclusion criteria

History of neurological disorders
Inability to keep relaxed
Magnetic materials inside the body
others

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Katsuya
Middle name
Last name Ogata

Organization

Graduate school of Medical Sciences, Kyushu University

Division name

Department of Clinical Neurophysiology, Neurological Institute

Zip code

812-8582

Address

Maidashi 3-1-1, Higashi-ku, Fukuoka

TEL

092-642-5543

Email

katuya@med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Katsuya
Middle name
Last name Ogata

Organization

Graduate school of Medical Sciences, Kyushu University

Division name

Department of Clinical Neurophysiology, Neurological Institute

Zip code

8128582

Address

Maidashi 3-1-1, Higashi-ku, Fukuoka

TEL

092-642-5543

Homepage URL


Email

katuya@med.kyushu-u.ac.jp


Sponsor or person

Institute

Department of Clinical Neurophysiology, Neurological Institute, Graduate school of Medical Sciences, Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science,
Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyushu University Institutional Review Board for Clinical Trials

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka

Tel

092-642-5082

Email

byshinsa@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


Other administrative information

Date of disclosure of the study information

2016 Year 10 Month 20 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

79

Results

The relationship between EEGs and MEPs were explored and it was found that higher EEG power at alpha band was related to higher MEP ampliutudes.

Results date posted

2019 Year 03 Month 18 Day

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

Completed

Date of protocol fixation

2016 Year 10 Month 19 Day

Date of IRB

2016 Year 10 Month 19 Day

Anticipated trial start date

2016 Year 10 Month 21 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 10 Month 19 Day

Last modified on

2019 Year 10 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028191


Research Plan
Registered date File name
2017/10/20 keikakusho.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name