Effect of Brain Stimulation with Transcranial Direct Current Stimulation (tDCS) on Two Brain Regions of DLPFC and OFC in Promoting Hot and Cold Performance
The aim of this study is to investigate tDCS on DLPFC and OFC in hot and cold executive performance
Design
The study is performed on 45 healthy adults in three groups of experimental and sham. All subjects were selected based on convenience sampling and randomly assigned to either group.
Settings and conduct
The study was a single-blind that only the subjects are unaware. The experimental study is a single-blind with two types of stimulation condition that the subjects only are unaware of. All subjects are selected based on convenience sampling and randomly assigned to either group. Initially, the goals of the plan are explained to individuals, then, after obtaining demographic information and written informed consent, Each individual completed four types of n-back, London Tower, Bart and Iowa executive performance software as a pre-test. Then, each subject was stimulated by tDCS in a quiet room and in a comfortable chair. Intervention was performed continuously for ten days, and at the end of the 10 days after the intervention, subjects completed four types of n-back, London Tower, Bart and Iowa executive performance software as a post-test.
Participants/Inclusion and exclusion criteria
Entry criteria: 1) Right hand 2) No previous history of brain surgery, epilepsy, seizure or brain injury 3) History of drug use or any disturbances in the axis of one or two, 4) No metal, prosthesis, shunt on the skull
Intervention groups
1) Experimental group: By stimulating tDCS at about 2 mA on areas:
anodal l-DLPFC/cathodal r-OFC
2) 1) Experimental group: By stimulating tDCS at about 2 mA on areas:
cathodal l-DLPFC/anodal r-OFC
3) Sham group: Electrode placement is the same as the first experimental group without any intervention.
Main outcome variables
Change in hot and cold executive functions
General information
Reason for update
Acronym
tDCS
IRCT registration information
IRCT registration number:IRCT20170429033690N2
Registration date:2019-11-23, 1398/09/02
Registration timing:registered_while_recruiting
Last update:2019-11-23, 1398/09/02
Update count:0
Registration date
2019-11-23, 1398/09/02
Registrant information
Name
Farzaneh Pouladi
Name of organization / entity
Shahid Bahonar university of Kerman
Country
Iran (Islamic Republic of)
Phone
+98 34 3325 7255
Email address
farzaneh@ens.uk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-21, 1398/07/29
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Brain Stimulation with Transcranial Direct Current Stimulation (tDCS) on Two Brain Regions of DLPFC and OFC in Promoting Hot and Cold Performance
Public title
The effect of tDCS on executive performance
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Right handed
No previous history of brain surgery, epilepsy, seizure, or brain damage
No history of drug use or any disturbance in the axis of one or two
Absence of metal, prosthesis, shunt on the skull
Exclusion criteria:
Age
From 20 years old to 32 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Available samples that meet the criteria for entry are randomly treated in either of the two treatment groups or as semi-therapies.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a blind blind study in which subjects were not aware of the type of intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Veterinary Faculty of Shahid Bahonar University of Kerman
Street address
Research Square, Shahid Bahonar University
City
Kerman
Province
Kerman
Postal code
7616914111
Approval date
2019-10-20, 1398/07/28
Ethics committee reference number
IR.UK.VETMED.REC.1398.024
Health conditions studied
1
Description of health condition studied
Assessment of executive functions in healthy individuals
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Performance scores on nback, London Tower, Iowa and Bart tests
Timepoint
Before intervention and 10 days after intervention
Method of measurement
Investigation of cold executive functions using nback and tower of London and hot executive functions using Iowa and Bart
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention involves anodal stimulation over the left DLPFC (F3) and cathodal stimulation over the right OFC (Fp2) at 2 mA to enhance cold executive performance. The intervention is performed continuously for 10 sessions that each session lasts 20 minutes
Category
Behavior
2
Description
The second intervention involves anodal stimulation over the right OFC (Fp2) and cathodal stimulation over the left DLPFC (F3) at 2 mA to enhance hot executive performance. The intervention is performed continuously for 10 sessions that each session lasts 20 minutes
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid bahonar university
Full name of responsible person
Masood Bagher
Street address
Research Square, Shahid Bahonar University
City
Kerman
Province
Kerman
Postal code
7616914111
Phone
+98 34 3132 2353
Email
f.pouladi80@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Bahonar University
Full name of responsible person
Masood Bagheri
Street address
Research Square, Shahid Bahonar University
City
Kerman
Province
Kerman
Postal code
7616914111
Phone
+98 34 3132 2353
Email
f.pouladi80@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Bahonar University
Proportion provided by this source
100
Public or private sector
Public
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
Shahid Bahonar University
Full name of responsible person
Farzaneh Pouladi
Position
phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Research Square, Shahid Bahonar University
City
Kerman
Province
Kerman
Postal code
7616914111
Phone
+98 34 3132 2353
Email
f.pouladi80@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Bahonar University
Full name of responsible person
Farzaneh Pouladi
Position
phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Research Square, Shahid Bahonar University
City
Kerman
Province
Kerman
Postal code
7616914111
Phone
+98 34 3132 2353
Email
f.pouladi80@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Bahonar University
Full name of responsible person
Farzaneh Pouladi
Position
phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Research Square, Shahid Bahonar University
City
Kerman
Province
Kerman
Postal code
7616914111
Phone
+98 34 3132 2353
Email
f.pouladi80@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some of the data is shared
When the data will become available and for how long
Access time will be from 1401
To whom data/document is available
only researcher
Under which criteria data/document could be used
In order to investigate by email
From where data/document is obtainable
By email with the corresponding author
What processes are involved for a request to access data/document