UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025720 |
|---|---|
| Receipt number | 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 | 2020/01/22 18:11:36 |
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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
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
hmizuta@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029593
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
