UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041905 |
|---|---|
| Receipt number | R000047833 |
| Scientific Title | Effect of repetitive transcranial magnetic stimulation on cognitive and motor performance in healthy volunteers |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2023/11/22 22:22:52 |
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Basic information
Public title
Effect of repetitive transcranial magnetic stimulation on cognitive and motor performance in healthy volunteers
Acronym
Improvements of cognitive and motor performance
Scientific Title
Effect of repetitive transcranial magnetic stimulation on cognitive and motor performance in healthy volunteers
Scientific Title:Acronym
Improvements of cognitive and motor performance
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect of repetitive transcranial magnetic stimulation on the cognitive and motor performance in humans, and to explore the underlying mechanisms by using kinematic and neurophysiological techniques.
Basic objectives2
Others
Basic objectives -Others
To explore the effect of repetitive transcranial magnetic stimulation on the motor learning and provide evidence for the rehabilitation programs in patients with nervous system disorders.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in amplitude and latency of motor evoked potentials (MEP)
Key secondary outcomes
Cognitive and motor function
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
10
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
rTMS to the unilateral primary motor cortex at 1Hz in 20 min
Interventions/Control_2
rTMS to the unilateral primary motor cortex at 10Hz in 20 min
Interventions/Control_3
rTMS to the unilateral premotor cortex at 1Hz in 20 min
Interventions/Control_4
rTMS to the unilateral premotor cortex at 10Hz in 20 min
Interventions/Control_5
rTMS to the unilateral supplementary motor area at 1Hz in 20 min
Interventions/Control_6
rTMS to the unilateral supplementary motor area at 10Hz in 20 min
Interventions/Control_7
rTMS to the unilateral prefrontal area at 1Hz in 20 min
Interventions/Control_8
rTMS to the unilateral prefrontal area at 10Hz in 20 min
Interventions/Control_9
rTMS to the unilateral parietal cortex at 1Hz in 20 min
Interventions/Control_10
rTMS to the unilateral parietal cortex at 10Hz in 20 min
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adult volunteers with written informed consent
Key exclusion criteria
(1) people with implanted medical devices (pacemaker, cochlear implant, deep brain stimulator, etc.) in the body
(2) people with intracranial magnetic materials (aneurysm clips, etc.)
(3) people with a history of epilepsy or spasm
(4) people with a history of cerebral nerve disease
(5) people receive cessation judgments from medical doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Nan |
| Middle name | |
| Last name | Liang |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
606-8507
Address
53 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3973
liang.nan.3z@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Nan |
| Middle name | |
| Last name | Liang |
Organization
Kyoto University
Division name
Graduate School of Medicine
Zip code
606-8507
Address
53 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3973
Homepage URL
liang.nan.3z@kyoto-u.ac.jp
Sponsor or person
Institute
Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Human Health Sciences, Graduate School of Medicine, Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University
Address
53 Shogoin-Kawahara-cho, Sakyo-ku, Kyoto, Japan
Tel
075-751-3973
liang.nan.3z@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
京都大学大学院医学研究科人間健康科学系専攻（京都府）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2025 | 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
| 2020 | Year | 09 | Month | 27 | Day |
Last modified on
| 2023 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047833
| 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 |
