UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Trial for unilateral spatital neglect treatment with repetitive transaranial magnetic stimulaion
Title of the study (Brief title)	Unilateral spatital neglect treatment with repetitive transaranial magnetic stimulaion
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Treatment efficacy of repetitive transcranial magnetic stimulation for unilateral spatitial neglect
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	CBS(Catherin Bergego Scale), Line Bisection Test, Cancellation task BIT(Behavioural inattention test)
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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	7 sessions of 1Hz, 500 pllse repetiteve transcranial magnetic stimulation(rTMS)every other day for two weeks
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	70 days-old <=
Age-upper limit	180 days-old >=
Gender	Male and Female
Key inclusion criteria	Unilateral neglect is detected among patients with recover phase stroke after onset 70 days.
Key exclusion criteria	Case with a cerebral aneurysm clipping technique and pacemaker implantation, an epilepsy history and the dementia
Target sample size	20

Research contact person
Name of lead principal investigator	Mamiko Sato
Organization	Fukui general hospital
Division name	Rehabilitaion department
Address	58-16-1, Egami-cho, Fukui-shi
TEL	0776-59-1300
Email	satomokonoori@yahoo.co.jp

Public contact
Name of contact person	Mamiko Sato
Organization	Fukui general hospital
Division name	Rehabilitaion department
Address	58-16-1, Egami-cho, Fukui-shi
TEL	0776-59-1300
Homepage URL
Email	satomokonoori@yahoo.co.jp

Sponsor
Institute	Fukui general hospital
Institute
Department

Funding Source
Organization	Fukui general hospital
Organization
Division
Category of Funding Organization	Other
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	2017 Year 02 Month 16 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 02 Month 16 Day
Anticipated trial start date	2017 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 15 Day
Last modified on	2017 Year 02 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030049