UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028863
Receipt number R000032838
Scientific Title Innovative cross-sectional research aimed at identifying neurophysiological biotypes of neuropsychiatric disorders using transcranial magnetic stimulation combined with high resolution electroencephalography
Date of disclosure of the study information 2017/09/01
Last modified on 2020/08/30 09:42:35

* 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

Innovative cross-sectional research aimed at identifying neurophysiological biotypes of neuropsychiatric disorders using transcranial magnetic stimulation combined with high resolution electroencephalography

Acronym

TMS-EEG study aimed at identifying biotypes of neuropsychiatric disorders

Scientific Title

Innovative cross-sectional research aimed at identifying neurophysiological biotypes of neuropsychiatric disorders using transcranial magnetic stimulation combined with high resolution electroencephalography

Scientific Title:Acronym

TMS-EEG study aimed at identifying biotypes of neuropsychiatric disorders

Region

Japan


Condition

Condition

neuropsychiatric disorders

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

unentered

Basic objectives2

Others

Basic objectives -Others

unentered

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

unentered

Key secondary outcomes

unentered


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

6

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

unentered

Interventions/Control_2

unentered

Interventions/Control_3

unentered

Interventions/Control_4

unentered

Interventions/Control_5

unentered

Interventions/Control_6

unentered

Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

13 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

unentered

Key exclusion criteria

unentered

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Yoshihiro
Middle name
Last name Noda

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan

TEL

03-3353-1211(61857)

Email

yoshi-tms@keio.jp


Public contact

Name of contact person

1st name Yoshihiro
Middle name
Last name Noda

Organization

Keio University School of Medicine

Division name

Department of Neuropsychiatry

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan

TEL

03-3353-1211(61857)

Homepage URL

http://psy.keiomed.jp/mtr-lab_mri-tms-eeg.html

Email

yoshi-tms@keio.jp


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Scientific Research, Japan Society for the Promotion of Science

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

Independent Ethics Committee, Keio University School of Medicine

Address

35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.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

慶應義塾大学病院(東京都)、慶應義塾大学医学部(東京都)


Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 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

2017 Year 08 Month 25 Day

Date of IRB

2017 Year 09 Month 21 Day

Anticipated trial start date

2017 Year 09 Month 21 Day

Last follow-up date

2022 Year 03 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

2017 Year 08 Month 28 Day

Last modified on

2020 Year 08 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032838


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name