臨床研究等提出・公開システム

Scientific Title	Exploring novel biomarkers of neuromuscular diseases using multichannel surface electromyography (s-EMG biomarker study)
Public Title	Exploring novel biomarkers of neuromuscular diseases using the new clinical neurophysiological method. (Neurophysiological biomarker study in neuromuscular diesases)

Contact for Scientific Queries	Name	Noto Yuichi
	Affiliation	University Hospital Kyoto Prefectural University of Medicine
	Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
	Telephone	+81-75-251-5793
	E-mail	y-noto@koto.kpu-m.ac.jp
Contact for Public Queries	Name	Noto Yu-ichi
	Affiliation	University Hospital Kyoto Prefectural University of Medicine
	Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN.
	Telephone	+81-75-251-5793
	E-mail	y-noto@koto.kpu-m.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 15, 2017
Actual date of first enrollment		Dec. 28, 2017
Target sample size		320
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	basic science
Key inclusion & exclusion criteria	Inclusion Criteria	Normal control:Adult subjects without abnormality in neurological examination and history of neurological diseases that affect the brain, nerves, and muscles. Disease group:Patients with neuromuscular diseases.
	Exclusion Criteria	History of having diabetes mellitus
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Stroke, amyotrophic lateral sclerosis, neuropathy, myasthenia gravis, miopathy
Intervention(s)		Multichannel surface electromyography is performed by voluntary contraction or electrical stimulation. Electrical stimulation is widely used in nerve conduction study and its safety is maintained.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Parameters obtained by multichannel surface electromyography (motor unit firing rate, distribution of muscle activity, and muscle conduction velocity.)
Secondary Outcome(s)		Medical history, neurological findings, image, and neurophysiological examination data.

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and Development
Secondary Sponsor	Not applicable

Source of Monetary Support	Research grant of life innovation center in Kyoto
Secondary Sponsor	Not applicable

Name of Certified Review Board	Kyoto Prefectural University of Medicine, Clinical Research Review Board
Address	465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, JAPAN. , Kyoto
Telephone	+81-75-251-5337
E-Mail	rinri@koto.kpu-m.ac.jp
Approval Status	Approval
Date of approval

Secondary ID(s)	UMIN000033500
Issuing Authority	University hospital Medical Information Network

Countries of Recruitment（Except Japan）	None

History of Changes

List of change history