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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025720
Receipt No. R000029593
Scientific Title Exploratory resarch on improvement of cognitive function by repetitive transcranial magnetic stimulation
Date of disclosure of the study information 2017/01/18
Last modified on 2019/03/18

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Basic information
Public title Exploratory resarch on improvement of cognitive function by repetitive transcranial magnetic stimulation
Acronym Exploratory resarch on improvement of cognitive function by rTMS
Scientific Title Exploratory resarch on improvement of cognitive function by repetitive transcranial magnetic stimulation
Scientific Title:Acronym Exploratory resarch on improvement of cognitive function by rTMS
Region
Japan

Condition
Condition Healthy volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Searching for the influence that rTMS has on cognitive functions such as attention switching and searching for a site and stimulation protocol with a large influence
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Wisconsin Card Sorting Test(WCST), Trail Making Test(TMT)
Key secondary outcomes Word Fluency test, Color Stroop Test (CST) etc.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Navigation-guided rTMS
site: right temporo-parietal junction
stimulation method: Continuous Theta burst stimulation
intensity: 80% active motor threshold(AMT)
number of pulses: 1800 pulses/session
number of sessions: 1 sessions
Interventions/Control_2 Navigation-guided rTMS
site: right temporo-parietal junction
stimulation method: Intermittent Theta burst stimulation
intensity: 80% active motor threshold(AMT)
number of pulses: 1800 pulses/session
number of sessions: 1 sessions
Interventions/Control_3 Navigation-guided rTMS
site: right temporo-parietal junction
stimulation method: Sham (placebo) stimulation
intensity: 0
number of pulses: 1800 pulses/session
number of sessions: 1 sessions
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Capability of informed consent
2) Aged 20-75 years-old
Key exclusion criteria 1) Implanted cardiac pacemaker
2) Surgical aneurysm clips
3) Neurostimulator
4) Implanted pumps
5) Metal fragments in body
6) Tattoos, permanent eyeliner (if ink contains metallic specks)
7) Diagnosis of neurological disorders (including epilepsy), substance dependence, or current serious medical illness (e.g. severe cardiac disease)
8) History of neurological disorders (including epilepsy), substance dependence, or head injury with loss of consciousness
9) Subjects with pregnancy or during lactation
10) Subjects who are judged as unsuitable for participation in this study
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Toshiya
Middle name
Last name Murai
Organization Kyoto University Graduate School of Medicine
Division name Department of Psychiatry
Zip code 606-8507
Address 54, Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-4947
Email hidehiko@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Hiroto
Middle name
Last name Mizuta
Organization Kyoto University Graduate School of Medicine
Division name Department of Psychiatry
Zip code 606-8507
Address 54, Shogoin-Kawahara-cho, Sakyo-ku, Kyoto
TEL 075-751-4947
Homepage URL
Email hmizuta@kuhp.kyoto-u.ac.jp

Sponsor
Institute Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
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 Kyoto University Certified Review Board
Address Yoshida-Konoe-cho, Sakyo-ku, Kyoto-shi, Kyoto, Japan
Tel 075-753-4680
Email ethcom@kuhp.kyoto-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 京都大学医学部附属病院/ Kyoto University Hospital

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 18 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 01 Month 10 Day
Date of IRB
2017 Year 02 Month 27 Day
Anticipated trial start date
2017 Year 04 Month 24 Day
Last follow-up date
2021 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 01 Month 18 Day
Last modified on
2019 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029593

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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