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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012190
Receipt No. 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

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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
Email 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
Email sekiguch@med.kobe-u.ac.jp

Sponsor
Institute Neurology, Kobe 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
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014245

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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