- Determine the effect of direct excitement stimulation on the level of positive emotions
- Determine the effect of excitement direct stimulation on working memory
Design
Sample size of 40 people, experimental study design with control group and random assignment with pre-test and post-test. design is double blinded.
Settings and conduct
The subjects are randomly assigned to test and control groups. Subsequently, by manipulating an independent variable, the effect of the intended test on the dependent variable is studied. Researchers are completely unaware of the placement of the subjects. Blind duplicate test will be performed. This test will be carried out in a laboratory environment. The intervention group will receive an electrical stimulus from the brain. In such a way that a given intensity will pass through his brain within 20 minutes. The control group also receives artificial brain electric stimulation from the skull, but it does not know if the device is off.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include the absence of any kind of psychiatric illness, right-handed, and age between 20-45 years.
Exit criteria include the presence of a current neurological disorder or its positive history (in particular seizure attacks), any other psychiatric disorder based on DSM-IV-TR axis 1 and 2, the use of drugs affecting the central nervous system , A history of epilepsy, brain surgery, a tumor, hit on the head.
Intervention groups
The intervention group will receive an electrical stimulus from the brain. In such a way that a given intensity will pass through his brain within 20 minutes. The control group also receives artificial brain electric stimulation from the skull, but it does not know if the device is off.
Main outcome variables
Transcranial Direct Current Stimulation؛ Enhance working memory; Create positive emotions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171022036932N2
Registration date:2018-11-30, 1397/09/09
Registration timing:registered_while_recruiting
Last update:2018-11-30, 1397/09/09
Update count:0
Registration date
2018-11-30, 1397/09/09
Registrant information
Name
Nima Ganji
Name of organization / entity
Faculty Member of Cognitive Science Research Group of Academic Center of Education, Culture and Res
Country
Iran (Islamic Republic of)
Phone
+98 77600055
Email address
nimaganji.psy@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-04, 1397/08/13
Expected recruitment end date
2018-12-16, 1397/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Transcranial Direct Current Stimulation on Positive Emotions and Working Memory in Healthy People
Public title
The Impact of Transcranial Stimulation on Positive Emotions and Working Memory
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Absence of any type of mental illness
right-handedness
age between 20-45 years
signing the consent form of the company in the study
Exclusion criteria:
The presence of a current neurological disorder or its positive history (especially seizure attacks)
Any psychiatric disorder based on DSM-IV-TR axis 1 and 2
Using of drugs affecting the central nervous system
Epileptic seizures
brain surgery
The presence of a tumor
A hit on the head that has led to anesthesia
Age
From 20 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Subjects are unaware of which of the two experimental or control groups are assigned. Measurement is done by one of the research colleagues who is completely unaware of the placement of the subjects. In other words, it will be done blindly.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Avicenna Research Institute of the Ethics Committee on Biomedical Research
Street address
Department of Cognitive Science, Jahad Alborz University, Dara Building, Poone Street, Golshahr
City
Karaj
Province
Alborz
Postal code
3138744746
Approval date
2017-10-21, 1396/07/29
Ethics committee reference number
IR.ACECR.Avicenna.REC.1396.15
Health conditions studied
1
Description of health condition studied
working memory, positive emotion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The Positive and Negative Affect Schedule (PANAS) - N Back Test
Timepoint
At the beginning of the study (before the study began) and one day after the intervention
Method of measurement
The Positive and Negative Affect Schedule (PANAS) - N Back Test
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group will be assessed before the intervention using the positive and negative affect scale (PANAS) and n-back task due to computer. Measurement is accomplished by one of the research partners who are completely unaware of the placement of the subjects in the two groups of intervention and control. This test will be carried out in a laboratory environment. Variables such as temperature, light and sound are controlled in all sessions. During the test, first, the performance of the tDCS device will be explained to the subjects, and the Consent letter will be signed by the subjects with the possible side effects of the test. Subjects will be given further details on the test process. A direct electric current is received from an electric current-generator device and transmitted to a pair of electrodes. The electrodes are carbon-based and placed inside the sponge coating that has been contained with serum. The intervention group will receive an electrical stimulus from the brain. In such a way that a certain intensity will pass through his brain in 20 minutes. After a short break, the subjects will again perform the Positive and Negative affective questionnaire (PANAS) and the n-back task due to computer. Then the money will be paid as a fee and subjects will be discharged at the end.
Category
Rehabilitation
2
Description
Control group: The control group will be assessed before the intervention using the positive and negative affect scale (PANAS) and n-back task due to computer. Measurement is accomplished by one of the research partners who are completely unaware of the placement of the subjects in the two groups of intervention and control. This test will be carried out in a laboratory environment. Variables such as temperature, light and sound are controlled in all sessions. During the test, first, the performance of the tDCS device will be explained to the subjects, and the Consent letter will be signed by the subjects with the possible side effects of the test. Subjects will be given further details on the test process. Then, the control group receives artificial brain electric stimulation from the skull. To artificially stimulate the location of anode and cathode electrodes, it will be the actual stimulation. While the flow generator outputs the current to 2 mA for 30 seconds, then it gradually returns to zero for 30 seconds, and the device turns off. But the electrodes will be on the subject for 20 minutes, and he will not be aware of the power off. After a short break, the subjects will again perform the Positive and Negative Affective Questionnaire (PANAS) and the n-back task due to computer. Then the money will be paid as a fee and subjects will be discharged at the end.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Jahad Alborz University
Full name of responsible person
Nima Gangi
Street address
Department of Cognitive Science, Jahad Alborz University, Dara Building, Poone Street, Golshahr
City
Karaj
Province
Alborz
Postal code
3138744746
Phone
+98 26 3457 4607
Email
nimaganji.psy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Mohammad Reza Poorabedi
Street address
Central buliding of Jihad-e-Daneshgahi, Facing the main door of Tehran University, Enghelab Avenue
City
Tehran
Province
Tehran
Postal code
4364 - 14155
Phone
+98 21 6695 2949
Fax
Email
secretariat@acecr.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian academic center for education culture and research
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
Iranian academic center for education culture and research
Full name of responsible person
Nima Gangi
Position
instructor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Department of Cognitive Science, Jahad Alborz University, Dara Building, Poone Street, Golshahr
City
Karaj
Province
Alborz
Postal code
3138744746
Phone
+98 262634574607
Email
nimaganji.psy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Nima Gangi
Position
instructor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Department of Cognitive Science, Jahad Alborz University, Dara Building, Poone Street, Golshahr
City
Karaj
Province
Alborz
Postal code
3138744746
Phone
+98 262634574607
Email
nimaganji.psy@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Nima Gangi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Department of Cognitive Science, Jahad Alborz University, Dara Building, Poone Street, Golshahr
City
karaj
Province
Alborz
Postal code
3138744746
Phone
+98 26 3457 4607
Email
nimaganji.psy@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
The total potential data includes the scores that subjects have received from positive emotional questionnaire and working memory task after unidentifing can be shared.
When the data will become available and for how long
Start the access period 6 months after sharing the results
To whom data/document is available
Researchers working in academic and research institutes
Under which criteria data/document could be used
The publication, or presentation or analysis of data should be done with the research author's permission
From where data/document is obtainable
Department of Cognitive Science, Jahad Alborz University, Dara Building, Poone Street, Golshahr
telephon: 02634574607
E-mail: cognitivescience.acecr@gmail.com
Responsive person: Dr.Nima Gangi
What processes are involved for a request to access data/document
If people want to ask for documents by e-mail, they must email the email address mentioned in the previous option. A response will be sent about a week to ten days later. In case of needing a personal appointment, the contact person will be contacted first by phone and appointment will be sent to the Office of the Department of Cognitive Science.