UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008467
Receipt number 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 17:24:06

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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 or person

Institute

Department of Rehabilitation Medicien, Keio University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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