UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019197 |
|---|---|
| Receipt number | R000022186 |
| Scientific Title | The evaluation of the effect of transcranial magnetic stimulation on brain blood flow and function by near infrared time-resolved spectroscopy |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2016/10/04 10:45:04 |
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Basic information
Public title
The evaluation of the effect of transcranial magnetic stimulation on brain blood flow and function by near infrared time-resolved spectroscopy
Acronym
The evaluation of the effect of transcranial magnetic stimulation on brain blood flow and function by near infrared time-resolved spectroscopy
Scientific Title
The evaluation of the effect of transcranial magnetic stimulation on brain blood flow and function by near infrared time-resolved spectroscopy
Scientific Title:Acronym
The evaluation of the effect of transcranial magnetic stimulation on brain blood flow and function by near infrared time-resolved spectroscopy
Region
| Japan |
Condition
Condition
cerebral vascular diseases and other neurological disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the changes of cerebral blood flow and function after TMS administration
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the changes of cerebral blood flow after the administration of repetitive TMS.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
quadripulse stimulation (QPS)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy volunteers who understand TMS
Key exclusion criteria
epilepsy, mental illness, CVD, etc
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshikazu Ugawa |
Organization
Fukushima Medical University
Division name
Neurology
Zip code
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-545-7111
Ugawa-tky@umin.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suguru Kadowaki |
Organization
Fukushima Medical University
Division name
Neurology
Zip code
Address
1 Hikarigaoka, Fukushima, Japan
TEL
024-547-1111
Homepage URL
skado@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Fukushima Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
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 | 01 | Day |
Last modified on
| 2016 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022186
