臨床研究等提出・公開システム

Scientific Title	Early diagnosis and prediction of motor neuron disease by ultrasound (Ultrasound in motor neuron disease)
Public Title	Early diagnosis and prediction of motor neuron disease by ultrasound

Study end date
Performed Number of Subjects
Baseline Characteristics
Participant Flow
Safety Conclusions
Efficacy Conclusions
Discussion and Overall Conclusions
Posted Date
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Results Links

Contact for Scientific Queries	Investigator Name	Hiroyuki Todo
	Investigator Organization	Hyogo-Chuo national Hospital
	Address	1314 Ohara, Sanda, Hyogom Japan
	TEL	+81-79-563-2121
	E-mail	wisteria1010@gmail.com
Contact for Public Queries	Contact Name	Hiroyuki Todo
	Contact Organization	Hyogo-Chuo national Hospital
	Address	1314 Ohara, Sanda, Hyogom Japan
	TEL	+81-79-563-2121
	E-mail	wisteria1010@gmail.com

Recruitment Status	RECRUITING

Date of First Enrollment		June. 24, 2016
Planned Number of Subjects		10
Nature of Investigation		Observational
Study Design	Description of Trial Design	prospective, observational
	Type of Control
	Trial Blinding Schema	open(masking not used)
	Randomized	No
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	probable or definite ALS in revised El Escorial criteria
	Exclusion Criteria	dementia, comorbid disease, hereditary ALS
	Minimum Age
	Maximum Age	No limit
	Sex of Participants	Both
Trial Indication(s)		MND/ALS
Intervention(s)		Intervention type: Name of intervention:None Dose form / Japanese Medical Device Nomenclature: Route of administration / Site of application:NOT APPLICABLE Dose per administration:none none none Dosing frequency / Frequency of use: none Planned duration of intervention: Intended dose regimen:none detailes of teratment arms:none Comparative intervention name:none Dose form / Japanese Medical Device Nomenclature:NOT APPLICABLE Route of administration / Site of application:NOT APPLICABLE Dose per administration:none none none Dosing frequency / Frequency of use: none Planned duration of intervention:none Intended dose regimen:none
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		muscle strengh, survival, ALSFRSR
Secondary Outcome(s)		fasciculation in each muscle

Primary Sponsor	Hiroyuki Todo
Secondary Sponsor	None

Sources of funding	Self-financing

Name of Ethics Committee	Ethics committee of National Health Organization Hyogo-Chuo National Hospital
Address
TEL
FAX
E-Mail
Ethics Committee Website
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval	None

Date of approved	June. 16, 2016

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Secondary Study ID	None
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Secondary Study ID	JMA-IIA00370
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	Mar. 18, 2019	(this page)	Changes
1	July. 27, 2018	Detail

List of change history