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The comparison of transcranial direct current stimulation(tDCS) effect over the right and left inferior frontal gyrus (IFG) and superior temporal gyrus (STG) on the accuracy and latency of picture naming in Persian patients with CVA induced aphasia.

Protocol summary

Summary
Objective: The aim of this research is to determine optimal stimulation condition for each patient individually, and to investigate long term effects of transcranial direct current stimulation on improvement of speed and accuracy of picture naming in patients with aphasia. Design: This study is an experimental and non-randomized clinical trial with pretest post test, single blind, and cross over design that will be done during two phases on 16 patients with aphasia induced by left hemisphere stroke. The first phase is related to determination of optimal stimulation region and the second is devoted to intervention. Setting and conduct: In the first phase, four different stimulation conditions will be tested during 2 sessions in each patient in order to determine optimal stimulation region: anodal stimulation over left inferior frontal gyrus, cathodic stimulation over right inferior frontal gyrus, anodal stimulation over left superior temporal gyrus, and cathodic stimulation over right superior temporal gyrus . An optimal stimulation state is the condition that speed and accuracy of naming is increased compared with the state of before stimulation. Participants: In this study 16 patients with left stroke aphasia and Anomia but without Apraxia and Dysarthria at the age of 40 to 85 years will be included. Intervention: In the second phase, Subjects will participate in 5 consecutive real stimulation sessions (20 min, 1mA), and 5 consecutive sham stimulation sessions (with 7 days interval). Main outcome measures: Accuracy and speed of picture naming before and after treatment are the primary outcome measures, and memory, executive function, and severity of aphasia are the secondary outcome measures.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050927820N1
Registration date: 2016-10-16, 1395/07/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-10-16, 1395/07/25
Registrant information
Name
Bahareh Rezaei
Name of organization / entity
Hamedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1571
Email address
e.rezaei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellors of the University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2016-10-22, 1395/08/01
Expected recruitment end date
2017-05-22, 1396/03/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
The comparison of transcranial direct current stimulation(tDCS) effect over the right and left inferior frontal gyrus (IFG) and superior temporal gyrus (STG) on the accuracy and latency of picture naming in Persian patients with CVA induced aphasia.
Public title
The effectiveness of tDCS on naming ability of patients with CVA induced aphasia.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age range in 40-85 years; More than 6 month from stroke onset; Right-handedness; left stroke; moderate to sever Anomia. Exclusion criteria: history of neurological disease such as epilepsy, dementia, and neuro-psychological disorders; visual or hearing sensory deficits; sever Dysarthria; more than once stroke; moderate to sever oral or speech Apraxia; Global Aphasia
Age
From 40 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
This study has the cross over design, that means the target and control group are the same.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Avenue, Daneshjo Boulevard, Evin, Tehran
City
Tehran
Postal code
1985713834
Approval date
2016-04-13, 1395/01/25
Ethics committee reference number
IR.USWR.REC.1395.75

Health conditions studied

1

Description of health condition studied
stroke
ICD-10 code
I69.3
ICD-10 code description
Sequelae of cerebral infarction

Primary outcomes

1

Description
Accuracy of picture naming
Timepoint
Before and after intervention
Method of measurement
Scores of Aphasia Naming Test

2

Description
speed of picture naming
Timepoint
Before and after intervention
Method of measurement
Computation of reaction time by DMDX Software

Secondary outcomes

1

Description
Memory
Timepoint
Before and after intervention
Method of measurement
Scores of Wechsler Memory Scale

2

Description
Executive function
Timepoint
Before and after intervention
Method of measurement
Scores of Wisconsin card sorting test

3

Description
Severity of aphasia
Timepoint
Before and after intervention
Method of measurement
P-WAB aphasia test

Intervention groups

1

Description
The intervention and control group are the same. Subjects will be received 5 consecutive real stimulation sessions (20 min, 1mA), and 5 consecutive sham stimulation sessions. The order of conditions will be randomized across subjects, and the all of patients will be blinded to the type of tDCS. There is a 7-day intersession interval between the real and the sham conditions.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchiyn Hospital
Full name of responsible person
Mehrdokht Mazdeh
Street address
Miirzadeh Eshghi, Farshchiyn Hospital, Hamedan
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellors of the University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Hamid Reza Khankeh
Street address
Kodakyar Avenue, Daneshjo Boulevard, Evin, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellors of the University of Social Welfare and Rehabilitation Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Bahareh Rezaei
Position
Faculty Member
Other areas of specialty/work
Street address
Hamedan University of Medical Sciences, Shahid Fahmideh Boulevard, Hamedan
City
Hamedan
Postal code
Phone
+98 38389112
Fax
Email
e.rezaei@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University Of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Fariba Yadegari
Position
Assistant Professor
Other areas of specialty/work
Street address
Kodakyar Avenue, Daneshjo Boulevard, Evin, Tehran
City
Tehran
Postal code
Phone
+212 2180013
Fax
Email
fa.yadegari@uswr.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan university of Medical Sciences
Full name of responsible person
Bahareh Rezaei
Position
Faculty Member
Other areas of specialty/work
Street address
Hamedan university of Medical Sciences, Shahid Fahmideh Boulevard, Hamedan
City
Hamedan
Postal code
Phone
+98 81 3838 9112
Fax
Email
e.rezaei@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
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Study Protocol
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Statistical Analysis Plan
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Informed Consent Form
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Clinical Study Report
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Analytic Code
empty
Data Dictionary
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