UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Studies on the usefulness of high-density surface electromyography in the diagnosis of neuromuscular disease
Title of the study (Brief title)	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	Kenji Sekiguchi
Organization	Kobe university hospital
Division name	Neurology
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	Kenji Sekiguchi
Organization	Kobe university hospital
Division name	Neurology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014245