UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012190 |
|---|---|
| Receipt number | R000014245 |
| Scientific Title | Studies on the usefulness of high-density surface electromyography in the diagnosis of neuromuscular disease |
| Date of disclosure of the study information | 2013/12/01 |
| Last modified on | 2016/11/02 18:23:26 |
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Basic information
Public title
Studies on the usefulness of high-density surface electromyography in the diagnosis of neuromuscular disease
Acronym
Studies on the usefulness of high-density surface electromyography in the diagnosis of neuromuscular disease
Scientific Title
Studies on the usefulness of high-density surface electromyography in the diagnosis of neuromuscular disease
Scientific Title:Acronym
Studies on the usefulness of high-density surface electromyography in the diagnosis of neuromuscular disease
Region
| Japan |
Condition
Condition
neuromuscular disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine safety and efficacy of electromyography using a newly created high-density surface electrode in the diagnosis of neuromuscular disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
parameters of single motor unit
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Ask to get the mild voluntary contraction on the subject attached the high-density surface electrode on the purpose muscle. Adjust the contraction force to be able to identify single motor unit and record 10 seconds for investigate the parameters of the waveforms.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects with sensorimotor disturbance of limbs which is considered necessary electro-diagnostic procedure.
Key exclusion criteria
The subjects with injury on the skin where the electrode attached.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Sekiguchi |
Organization
Kobe university hospital
Division name
Neurology
Zip code
Address
7-5-2 kusunoki-cho, chuo-ku, Kobe
TEL
078-382-5885
sekiguch@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenji Sekiguchi |
Organization
Kobe university hospital
Division name
Neurology
Zip code
Address
7-5-2 kusunoki-cho, chuo-ku, Kobe
TEL
078-382-5885
Homepage URL
sekiguch@med.kobe-u.ac.jp
Sponsor or person
Institute
Neurology, Kobe 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
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
| 2013 | Year | 12 | 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
Completed
Date of protocol fixation
| 2013 | Year | 10 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 02 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 02 | Month | 09 | Day |
Date analysis concluded
| 2016 | Year | 02 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 31 | Day |
Last modified on
| 2016 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014245
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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