UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000019505
Receipt No. 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 (Ver. 6)

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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
Email 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
Email nojima@met.nagoya-u.ac.jp

Sponsor
Institute Nagoya University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022553