UMIN-CTR Clinical Trial

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	24
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	Completed
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	2019 Year 10 Month 10 Day
Date of closure to data entry
Date trial data considered complete	2019 Year 10 Month 10 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 01 Month 18 Day
Last modified on	2020 Year 01 Month 22 Day

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