UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026142
Receipt number R000030049
Scientific Title Trial for unilateral spatital neglect treatment with repetitive transaranial magnetic stimulaion
Date of disclosure of the study information 2017/02/16
Last modified on 2017/02/15 14:13:14

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Basic information

Public title

Trial for unilateral spatital neglect treatment with repetitive transaranial magnetic stimulaion

Acronym

Unilateral spatital neglect treatment with repetitive transaranial magnetic stimulaion

Scientific Title

Trial for unilateral spatital neglect treatment with repetitive transaranial magnetic stimulaion

Scientific Title:Acronym

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

1st name
Middle name
Last name Mamiko Sato

Organization

Fukui general hospital

Division name

Rehabilitaion department

Zip code


Address

58-16-1, Egami-cho, Fukui-shi

TEL

0776-59-1300

Email

satomokonoori@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mamiko Sato

Organization

Fukui general hospital

Division name

Rehabilitaion department

Zip code


Address

58-16-1, Egami-cho, Fukui-shi

TEL

0776-59-1300

Homepage URL


Email

satomokonoori@yahoo.co.jp


Sponsor or person

Institute

Fukui general hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2017 Year 02 Month 16 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030049


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name