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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031597
Receipt No. 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 2018/03/05

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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
Middle name
Last name Yasuo Terao
Organization Faculty of Medicine, Kyorin University
Division name Department of Cell Physiology
Zip code
Address 6-20-2 Shinkawa, Mitaka, Tokyo
TEL +81422475511
Email yterao-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasuo Terao
Organization Faculty of Medicine, Kyorin University
Division name Department of Cell Physiology
Zip code
Address 6-20-2 Shinkawa, Mitaka, Tokyo
TEL +81422475511
Homepage URL
Email yterao-tky@umin.ac.jp

Sponsor
Institute Faculty of Medicine, Kyorin University
Institute
Department

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
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 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
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
2018 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.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


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