臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 29, 2015
Last modified on	Oct. 30, 2015
Trial ID	jRCT1090220226

Scientific Title	rTMS combined with rehabilitation for post-stroke hemiparesis : Evaluation by MRS (rTMS and rehabilitation therapy for hemiparesis)
Public Title	rTMS combined with rehabilitation for post-stroke hemiparesis : Evaluation by MRS

Contact for Scientific Queries	Investigator Name	Masayoshi Minami
	Investigator Organization	The Izumi memorial hospital
	Address	1-3-7, Motogi, Adachi-Ku, Tokyo 123-0853, Japan
	TEL	+81-3-5888-2111
	E-mail	tealoop@gmail.com
Contact for Public Queries	Contact Name	Masayoshi Minami
	Contact Organization	The Izumi memorial hospital
	Address	1-3-7, Motogi, Adachi-Ku, Tokyo 123-0853, Japan
	TEL	+81-3-5888-2111
	E-mail	tealoop@gmail.com

Recruitment Status	RECRUITING

Date of First Enrollment		Nov. 26, 2015
Planned Number of Subjects		40
Nature of Investigation		Interventional
Study Design	Description of Trial Design	Experimental Study
	Type of Control
	Trial Blinding Schema	double blind
	Randomized	Yes
Trial Phase		N/A
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Brunnstrom stage for hand-fingers of 4 or 5; (2) time between the onset of stroke and intervention of more than 12 months; (3) history of a single stroke only (no bilateral cerebrovascular lesion); (4) no cognitive impairment with a pretreatment MiniMental State Examination score of more than 26; (5) clinical confirmation of a plateau state, representing no score increase in the Fugl-Meyer Assessment (FMA) in the latest three months; (6) no pathological conditions known to be contraindications for rTMS in the guidelines suggested by Wassermann;
	Exclusion Criteria	(1)active physical or mental illness requiring medical management; (2)history of seizure within one-year preceding theintervention; (3)documented epileptic discharge on pretreatmentelectroencephalogram; (4)current use of antiepileptic medications for the prevention of seizure;
	Minimum Age	18age old over
	Maximum Age	90age old under
	Sex of Participants	Both
Trial Indication(s)		post-stroke hemiparesis
Intervention(s)		Intervention type:BEHAVIOUR,DEVICE Name of intervention:rTMS combined with rehabilitation Dose form / Japanese Medical Device Nomenclature:DEVICE MagPro R30 Route of administration / Site of application:PERCUTANEOUS Dose per administration: Dosing frequency / Frequency of use: once per day Planned duration of intervention:22 days Intended dose regimen:40mins per day detailes of teratment arms:20 patients in the chronic post-stroke stage with hemiparesis will be recruited for this study from October 29, 2014 until March 31, 2021. Comparative intervention name:rehabilitation Dose form / Japanese Medical Device Nomenclature:OTHER Route of administration / Site of application: Dose per administration: Dosing frequency / Frequency of use: Planned duration of intervention:22 days Intended dose regimen:
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		efficacy
Secondary Outcome(s)		MRS and Fugl-Meyer Assessment

Primary Sponsor	The Izumi memorial hospital
Secondary Sponsor	The Jikei University School of Medicine

Sources of funding	the study funding of the Izumi memorial hospital

Name of Ethics Committee	the ethics committee of The Izumi memorial hospital
Address
TEL	+81-3-5888-2111
FAX	+81-3-5888-2112
E-Mail	tealoop@gmail.com
Ethics Committee Website	http://www.izumikinen.or.jp/
Committee Approval Number
Approved by Ethics Committee	Yes
Reason for Unapproval

Date of approved	June. 19, 2015

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Secondary Study ID	Nill Known
Issuer Name

Secondary Study ID	JMA-IIA00226
Issuer Name

Countrie(s) of Recruitment	Japan

History of Changes

No	Publication date
2	Oct. 30, 2015	(this page)	Changes
1	Oct. 29, 2015	Detail

List of change history