UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031597
Receipt number R000034708
Scientific Title Enhancement of higher brain function of humans by transcranial magnetic stimulation and investigation of the mechanism of enhancement
Date of disclosure of the study information 2018/03/05
Last modified on 2020/03/06 10:12:45

* 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

Enhancement of higher brain function of humans by transcranial magnetic stimulation and investigation of the mechanism of enhancement

Acronym

Enhancement of higher brain function of humans by transcranial magnetic stimulation

Scientific Title

Enhancement of higher brain function of humans by transcranial magnetic stimulation and investigation of the mechanism of enhancement

Scientific Title:Acronym

Enhancement of higher brain function of humans by transcranial magnetic stimulation

Region

Japan


Condition

Condition

neurological patients

Classification by specialty

Neurology Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the cognitive changes related to neurological disorders with special reference to temporal processing, language function

Basic objectives2

Others

Basic objectives -Others

elucidation of pathophysiology

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

various measures of cognitive functions

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

subjects in which TMS/rTMS is performed

Interventions/Control_2

subjects in which TMS/rTMS is not performed

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


Not applicable

Gender

Male and Female

Key inclusion criteria

patients with neurological disorders without dementia, with a Montreal Cognitive Assessment score of or more than 25

Key exclusion criteria

demented subjects, those without ability to consent to participate

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Yasuo
Middle name
Last name Terao

Organization

Faculty of Medicine, Kyorin University

Division name

Department of Cell Physiology

Zip code

181-8611

Address

6-20-2 Shinkawa, Mitaka, Tokyo

TEL

08065061023

Email

yterao-tky@umin.ac.jp


Public contact

Name of contact person

1st name Yasuo
Middle name
Last name Terao

Organization

Faculty of Medicine, Kyorin University

Division name

Department of Medical Physiology

Zip code

181-8611

Address

6-20-2 Shinkawa, Mitaka, Tokyo

TEL

+81422475511

Homepage URL


Email

yterao-tky@umin.ac.jp


Sponsor or person

Institute

Faculty of Medicine, Kyorin University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the promotion of Science, Ministry of Education, Science and Culture

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

Faculty of Medicine Research Ethics Committee, Kyorin University

Address

6-20-2 Shinkawa, Mitaka, Tokyo

Tel

+81422475511

Email

igakuks@ks.kyorin-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

2018 Year 03 Month 05 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 10 Month 21 Day

Date of IRB

2017 Year 04 Month 02 Day

Anticipated trial start date

2017 Year 12 Month 01 Day

Last follow-up date

2022 Year 10 Month 21 Day

Date of closure to data entry

2022 Year 10 Month 21 Day

Date trial data considered complete

2022 Year 10 Month 21 Day

Date analysis concluded

2027 Year 10 Month 21 Day


Other

Other related information



Management information

Registered date

2018 Year 03 Month 05 Day

Last modified on

2020 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034708


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name