Investigating the effects of single-site and double-site transcranial direct current stimulation on motor and cognitive performances in gymnast men
Design
In the present study, 16 subjects will be randomly exposed to four different conditions in an intra-group and double-blind manner.
Settings and conduct
The present research will be conducted in the Faculty of Sports Sciences of Razi University of Kermanshah. After selecting the subjects and getting familiar with the research process, each subject will be exposed to four different conditions of electrical stimulation of the brain with a random combination. The main researcher and the subjects will not be aware of the type of stimulation received in each session.
Participants/Inclusion and exclusion criteria
Inclusion criteria:The person must be a beginner and have less than 2 months of participation in gymnastics. Age range of 20-30 years.
Exclusion criteria: The person has a history of neurological disorders, balance, fear or dissatisfaction with stimulation and any metal implants.
Intervention groups
This study was done within a group in which the subjects were randomly exposed to four different conditions of brain stimulation including: 1) anodal stimulation of the C3 area; 2) anodal stimulation of the F3 area; 3) stimulation of C3 and F3 areas; 4) sham stimulation, will be placed.
Main outcome variables
Motor and cognitive function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231219060467N1
Registration date:2024-04-10, 1403/01/22
Registration timing:registered_while_recruiting
Last update:2024-04-10, 1403/01/22
Update count:0
Registration date
2024-04-10, 1403/01/22
Registrant information
Name
ahmed lafta
Name of organization / entity
Razi university
Country
Iran (Islamic Republic of)
Phone
+98 903 250 7110
Email address
ahmedabdullahlafta2023@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-04-18, 1403/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of single-site and double-site transcranial direct current stimulation on motor and cognitive performances in gymnast men
Public title
"Effects of transcranial direct current stimulation on gymnast men"
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
The person must be a beginner and have less than 2 months of participation in gymnastics
Compliance with the age range of 20-30 years
Having normal or corrected vision
Exclusion criteria:
Having a history of neurological disorders or any disease that prevents entering the research process.
Having any metal implants in the brain
History of balance disorder and frequent positional vertigo
Fear or dissatisfaction with electrical stimulation of the brain
Age
From 20 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
16
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, in order to randomize the order of subject exposure to four different conditions (4 different types of electrical stimulation of the brain), the Latin square method will be used. For this purpose, first, using the website www.random.org, each subject will be randomly assigned a number between 1 and 12 as an identification code. Then, the English letters D, C, B, A are assigned to four intervention conditions and a Latin square will be created with four rows and four columns. After creating the Latin square, participants number 1 to 3 in the sequence of the first row, participants 4 to 6 in the sequence of the second row, participants 7 to 9 in the sequence of the third row and participants 10 to 12 in the sequence of the fourth row will be placed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, the researcher and participants will be blinded to the type of transcranial electrical stimulation used and the location of stimulation in each session. In the current study, the Neurostim stimulation device was used to induce direct current electrical stimulation in four separate sessions and four different modes including: 11) anodal stimulation of the C3 area; 2) anodal stimulation of the F3 area; 3) simultaneous stimulation of C3 and F3 areas; 4) Unreal stimulation (sham stimulation) will be used. For this purpose, a person outside the research team will be responsible for applying electrical stimulation in four experimental sessions. In order to blind the participants, after they sit on a special chair, the electrical stimulation device of the brain is hidden from their sight and covered by a cover completely, and the electrodes will be placed on the desired areas by the examiner. In order to blind the researcher, before the intervention, the researcher leaves the laboratory and returns to the test site after the stimulation period has passed and the electrodes are removed and the stimulation device is turned off. Also, in the sham stimulation mode, according to standard protocols, the active current is induced on the head for 30 seconds to induce the same sensation as the active stimulation mode, and then the current is cut off and the stimulation is deactivated.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Razi University Research Ethics Committee
Street address
Taq Bostan, University Street, Razi University
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2023-10-18, 1402/07/26
Ethics committee reference number
IR.RAZI.REC.1402.080
Health conditions studied
1
Description of health condition studied
The participants are healthy and athletic people.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
working memory
Timepoint
before and after the intervention in each session
Method of measurement
N-BACK TEST
Secondary outcomes
1
Description
Hand-eye coordination
Timepoint
before and after the intervention in each session
Method of measurement
Lafayette company's automatic drawing company
2
Description
Two-handed coordination
Timepoint
before and after the intervention in each session
Method of measurement
Two-handed coordination tool of Lafayette company
3
Description
Reaction time
Timepoint
before and after the intervention in each session
Method of measurement
Reaction time measuring software of Sina company
4
Description
Selective attention
Timepoint
before and after the intervention in each session
Method of measurement
Stroop test
Intervention groups
1
Description
Intervention 1: will receive 20 minutes of anodal stimulation of the M1 area with an intensity of 2 mA. In order to stimulate, the Neurostim stimulation device manufactured by Medina Teb Company will be used. The target area in the brain is identified using the 10-20 international brain mapping system and stimulation is performed using special stimulation electrodes and a special electroencephalogram cap.
Category
Other
2
Description
Intervention 1: will receive 20 minutes of anodal stimulation of the left DLPFC area with an intensity of 2 mA. In order to stimulate, the Neurostim stimulation device manufactured by Medina Teb Company will be used. The target area in the brain is identified using the 10-20 international brain mapping system and stimulation is performed using special stimulation electrodes and a special electroencephalogram cap.
Category
Other
3
Description
Intervention 3: will receive 20 minutes of simultaneous stimulation of M1 and DLPFC with an intensity of 2 mA. In order to stimulate, the Neurostim stimulation device manufactured by Medina Teb Company will be used. The target area in the brain is identified using the 10-20 international brain mapping system and stimulation is performed using special stimulation electrodes and a special electroencephalogram cap.
Category
Other
4
Description
Intervention 4: will receive 20 minutes of unreal stimulation (sham stimulation) with an intensity of 2 mA. In order to stimulate, the Neurostim stimulation device manufactured by Medina Teb Company will be used. The target area in the brain is identified using the 10-20 international brain mapping system and stimulation is performed using special stimulation electrodes and a special electroencephalogram cap.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Sports Sciences, Razi University
Full name of responsible person
Faculty of Sports Sciences, Razi University
Street address
Taqbestan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
ahmedabdullahlafta2023@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Farzaneh Ghadami
Street address
Taqbestan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
gandomif@razi.ac.ir
Grant name
Research and Technology Vice Chancellor of Razi University
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University of Kermanshah
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
Razi University of Kermanshah
Full name of responsible person
Ahmed Abdullah Lafteh
Position
Student
Latest degree
Master
Other areas of specialty/work
motor behavior
Street address
Taq Bostan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
09647706922199
Email
ahmedabdullahlafta2023@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Ahmed Abdullah Lafteh
Position
student
Latest degree
Master
Other areas of specialty/work
motor behavior
Street address
Taqbestan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
09647706922199
Email
ahmedabdullahlafta2023@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Razi University of Kermanshah
Full name of responsible person
Ahmed Abdullah Lafteh
Position
Student
Latest degree
Master
Other areas of specialty/work
Neurology
Street address
Taqbestan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
09647706922199
Email
ahmedabdullahlafta2023@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after de-identifying subjects.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
researchers
Under which criteria data/document could be used
For meta-analytic research
From where data/document is obtainable
If you need to receive the documents, send an email to Ahmed Laftah, the researcher, with the email address: ahmedabdullahlfth@gmail.com.
What processes are involved for a request to access data/document
In case of an official request, stating the relevant reasons and mentioning the complete details, the data will be sent via email after 72 hours.