UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019505 |
|---|---|
| Receipt number | R000022553 |
| Scientific Title | The effect of static magnetic stimulation on physical, sensory and cognitive function. |
| Date of disclosure of the study information | 2015/10/26 |
| Last modified on | 2019/06/19 15:15:48 |
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Basic information
Public title
The effect of static magnetic stimulation on physical, sensory and cognitive function.
Acronym
The effect of static magnetic stimulation on physical, sensory and cognitive function.
Scientific Title
The effect of static magnetic stimulation on physical, sensory and cognitive function.
Scientific Title:Acronym
The effect of static magnetic stimulation on physical, sensory and cognitive function.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to clarify The effect of static magnetic stimulation on physical, sensory and cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor function: 9HP-test
Sensory function: tactile function test
EEG: SEP
pre, post-0min, 15-min, 30-min, 24-hours later
Key secondary outcomes
Motor function: Reaction time
Sensory function: tactile function test
EEG: P300, CNV
pre, post-0min, 15-min, 30-min, 24-hours later
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Static magnetic stimulation
Interventions/Control_2
Sham
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy volunteers
Key exclusion criteria
under 20 years-old
patients with cardiac pacemake
patients with epilepsy
patients with indwelling catheter
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ippei |
| Middle name | |
| Last name | Nojima |
Organization
Graduate School of Medicine, Nagoya University
Division name
Rehabilitation
Zip code
461-8673
Address
1-1-20 Daiko-minami, Higashi-ku, Nagoya-shi
TEL
052-719-1365
nojima@met.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Ippei |
| Middle name | |
| Last name | Nojima |
Organization
Graduate School of Medicine, Nagoya University
Division name
Rehabilitation
Zip code
461-8673
Address
1-1-20 Daiko-minami, Higashi-ku, Nagoya-shi
TEL
052-719-1365
Homepage URL
nojima@met.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Nagoya University
Address
65, Tsurumai, Syowa-ku, Nagoya
Tel
052-744-2479
iga-shinsa@adm.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
Original tSMS study reported that stimulation over the human primary motor cortex (M1) can reduce the output of motor cortex. Recent our study showed that application of tSMS during practice over contralateral M1 did not impair online learning, but rather facilitated offline learning as compared to sham stimulation and stimulation for other cortical area. This finding suggested that the modulation of the M1 using tSMS can enhance offline motor learning in an implicit task.
Results date posted
| 2019 | Year | 06 | Month | 19 | Day |
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
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2019 | 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
| 2015 | Year | 10 | Month | 26 | Day |
Last modified on
| 2019 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022553
| 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 |
