Protocol summary

Study aim
The effect of tDCS on naming speed and verbal fluency
Design
Applicants are randomly divided into two groups of intervention and control
Settings and conduct
The tDCS device will apply with a specific pattern in 10 sessions of 20 minutes on two groups. The test of naming speed test and verbal fluency test are taken for both groups.
Participants/Inclusion and exclusion criteria
Including criteria: 20-33 years old, monolingual (Persian), right-handed. Exclusion criteria: Pregnancy, Having seizure, Heart diseases, Using of heart battery and other implanted bioelectric devices
Intervention groups
Intervention group: 12 youth of Eqlid city with 22-33 years old which tDCS will apply with intensity of ... mA at head skin and region of ... and ... for 7 sessions of 20 minutes period. Control group: 12 youth of Eqlid city with 22-33 years old which tDCS with the same pattern of Intervention group will apply but at off (sham) mode
Main outcome variables
Speed Naming Verbal Fluency

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190620043953N1
Registration date: 2019-09-22, 1398/06/31
Registration timing: retrospective

Last update: 2019-09-22, 1398/06/31
Update count: 0
Registration date
2019-09-22, 1398/06/31
Registrant information
Name
Amir Sharafat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3828 6667
Email address
dr.sharafat.amir@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-27, 1398/05/05
Expected recruitment end date
2019-08-16, 1398/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Transcranial Direct Current Stimulation (tDCS) on naming speed and verbal fluency in youth of Eqlid city
Public title
The effect of Transcranial Direct Current Stimulation (tDCS) on naming speed and verbal fluency
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
20-33 years old monolingual (Persian) right-handed
Exclusion criteria:
Pregnancy Having seizure Heart diseases Using of heart battery and other implanted bioelectric devices
Age
From 20 years old to 33 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomized
Blinding (investigator's opinion)
Single blinded
Blinding description
The tDCS device is running off (sham mode) for participants in the sham group
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahwaz Shahid Chamran University
Street address
Ahwaz Shahid Chamran University, Golestan Blvd., Ahwaz City
City
Ahwaz
Province
Khouzestan
Postal code
6135813453
Approval date
2019-07-23, 1398/05/01
Ethics committee reference number
IR.SCU.REC.1398.24326381

Health conditions studied

1

Description of health condition studied
Naming speed and verbal fluency
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Naming speed score
Timepoint
before tDCS, during tDCS and after each meeting tDCS
Method of measurement
naming speed test

2

Description
verbal fluency score
Timepoint
before tDCS, during tDCS and after each meeting tDCS
Method of measurement
verbal fluency test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 12 youth of Eqlid city with 22-33 years old which tDCS will apply with intensity of ... mA at head skin and region of ... and ... for 7 sessions of 20 minutes period
Category
N/A

2

Description
Control group: 12 youth of Eqlid city with 22-33 years old which tDCS with the same pattern of Intervention group will apply but at off (sham) mode
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Aramesh Clinic with the approval of Shahid Chamran University
Full name of responsible person
Fahimeh Sharifi
Street address
No 95, Cheraqi Alley, Imam Khomeini Street.
City
Eqlid
Province
Fars
Postal code
7381636337
Phone
+98 71 4452 5729
Email
Last_vernal_blossom@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahwaz Shahid Chamran University
Full name of responsible person
Manijeh Shehni Yeilagh
Street address
Shahid chamran university, Golestan Blvd., Ahwaz City
City
Ahwaz
Province
Khouzestan
Postal code
۶۱۳۵۸۱۳۴۵۳
Phone
+98 61 3333 0011
Email
shehniyailaghm@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahwaz Shahid Chamran University
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahwaz Shahid Chamran University
Full name of responsible person
Fahimeh sharifi
Position
Master Student of Cognitive science
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
No. 95. Imam Khomeini Street., Cheraqi Alley
City
Eqlid
Province
Fars
Postal code
7381636337
Phone
+98 71 4452 5729
Email
last_vernal_blossom@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amir Sharafat
Position
Neurologist
Latest degree
Specialist
Other areas of specialty/work
Neuroscience
Street address
No.6,Binesh21 Ave,Javad Blvd.,Yazd,
City
Yazd
Province
Yazd
Postal code
8915868584
Phone
+98 35 3828 6667
Email
dr.sharafat.amir@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Chamran University
Full name of responsible person
Fahimeh Sharifi
Position
Cognitive science Collage Student
Latest degree
Bachelor
Other areas of specialty/work
Speech therapy
Street address
No. 95. Cheraqi Alley,. Imam Khomeini Street
City
Eqlid
Province
Fars
Postal code
7381636337
Phone
+98 71 4452 5729
Email
last_vernal_blossom@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no need to publish the individual participant data and only the collected data will be published
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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