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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008467
Receipt No. R000009957
Scientific Title Transcranial direct current stimulation combined with speech therapy among patients with aphasia
Date of disclosure of the study information 2012/07/20
Last modified on 2015/08/25

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Basic information
Public title Transcranial direct current stimulation combined with speech therapy among patients with aphasia
Acronym Transcranial direct current stimulation for patients with aphasia
Scientific Title Transcranial direct current stimulation combined with speech therapy among patients with aphasia
Scientific Title:Acronym Transcranial direct current stimulation for patients with aphasia
Region
Japan

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

Objectives
Narrative objectives1 We study the effect of transcranial direct current stimulation combined with speech therapy for non-fluently aphasia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Reaction time for naming task
Boston naming test
Key secondary outcomes Cerebral blood flow
SLTA
FIM communication

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Transcranial direct current stimulation + speech therapy
Interventions/Control_2 Sham stimulation + speech therapy
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Time from stroke onset over 6 months
FIM comprehension item score>5
Key exclusion criteria Patients implanted pacemaker, shunt or other implanted metal

Medical history of seizure or the other medical complication which inhibit to recruit this experiment.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Fujiwara
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomach, Shinjuku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomach, Shinjuku, Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Department of Rehabilitation Medicien, Keio University School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
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
2012 Year 07 Month 20 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 Terminated
Date of protocol fixation
2012 Year 06 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 07 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
2012 Year 07 Month 18 Day
Last modified on
2015 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009957

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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