UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023658 |
|---|---|
| Receipt number | R000027248 |
| Scientific Title | Comparison between activation of contralateral and ipsilateral corticofugal pathway in deltoid muscle in human. |
| Date of disclosure of the study information | 2016/09/15 |
| Last modified on | 2019/03/26 11:52:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison between activation of contralateral and ipsilateral corticofugal pathway in deltoid muscle in human.
Acronym
Comparison between activation of contralateral and ipsilateral corticofugal pathway.
Scientific Title
Comparison between activation of contralateral and ipsilateral corticofugal pathway in deltoid muscle in human.
Scientific Title:Acronym
Comparison between activation of contralateral and ipsilateral corticofugal pathway.
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) The revelation of reliability about method of transcranial magnetic stimulation in deltoid muscle.
2) The acquisition of reference data which are comparable to patients of central nerve system disease by measuring the activation of ipsilateral and corticospinal corticofugal pathways in human.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
active motor threshold
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Contralateral or ipsilateral primary motor area is stimulated by means of magnetic stimulator (Magstim 200, The Magstim Company Ltd, UK), and motor evoked potentials are measured from deltoid muscle. The measurements are performed during two separate testing sessions, separated by more than 48 hours. It takes around 1.5-2 hours at time to measure.
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Volunteer older than age 20 years old who does not have the past of a nerve, the muscular disorder
Key exclusion criteria
(1)Metal is buried in the part near the stimulation part
(2)The past of epilepsy
(3)The past of the intracranial lesion
(4)Internal use career of anticonvulsant
(5)Sleep shortage
(6)Alcohol dependence
(7)The pregnancy
(8)serious heart disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Meigen Liu |
Organization
School of Medicine, Keio University
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3833
meigenliukeio@me.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Miho Hiramoto |
Organization
School of Medicine, Keio University
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-5363-3833
Homepage URL
miho-hiramoto@keio.jp
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
School of Medicine, Keio 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
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
| 2016 | Year | 09 | Month | 15 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 17 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027248
