Protocol summary

Study aim
Effects of transcranial direct current stimulation of the primary motor cortex and dorsolateral prefrontal cortex on anaerobic performance, the amplitude of muscle electromyography, perceived exertion, pleasure sensation, arousal, cognitive function, and choice reaction time during and after maximal anaerobic task
Design
A within-subject, counterbalanced by the use of Latin Square, and double-blind study. Fifteen subjects will be exposed to 3 different conditions.
Settings and conduct
This study is conducted at Razi University. After recruiting subjects and their familiarization, each subject is exposed to 3 different conditions of brain electrical stimulation in random order and then, will perform 3 bouts of 30-second Wingate anaerobic test with 4 minutes of recovery in between.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Aged between 18 to 30 years old; Student of sports sciences, third semester or higher; Reside in Kermanshah; Being familiar and having experience in performing anaerobic training; Getting the certification of no prohibition of participating in the exercise. Exclusion Criteria: Suffering from any cardiovascular, pulmonary, and metabolic diseases; History of seizures, epilepsy, or other neurological diseases; Existence of implantable devices or pacemakers in the body. Tobacco and alcohol consumption Refusal to give informed consent
Intervention groups
In this within-subject and counterbalanced study, participants will be exposed to 3 different conditions of brain stimulation including 1) Anodal stimulation of the primary motor cortex, 2) Anodal stimulation of the dorsolateral prefrontal cortex, 3) Sham stimulation (placebo effect) for 20 minutes and 2 milliamperes intensity.
Main outcome variables
Change in anaerobic performance, perceived exertion, electromyography, cognitive function, and reaction time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210617051606N5
Registration date: 2022-02-04, 1400/11/15
Registration timing: registered_while_recruiting

Last update: 2022-02-04, 1400/11/15
Update count: 0
Registration date
2022-02-04, 1400/11/15
Registrant information
Name
Ehsan Amiri
Name of organization / entity
Razi University
Country
Iran (Islamic Republic of)
Phone
+98 83 3845 8428
Email address
e.amiri@razi.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-31, 1400/11/11
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Transcranial Direct Current Stimulation on Athletic and Cognitive Performance During and After Maximal Anaerobic Task
Public title
Non-invasive brain stimulation and anaerobic performance
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 18 to 30 years old Student of physical education and sport sciences, third semester or higher Reside in Kermanshah city Being familiar and having experience in performing anaerobic training Getting the certification of no prohibition of participating in the exercise training program from a specialist
Exclusion criteria:
Suffering from any cardiovascular, pulmonary and metabolic diseases History of seizures, epilepsy, or other neurological diseases Existence of implantable devices or pacemakers in the body Tobacco and alcohol consumption Refusal to give informed consent
Age
From 18 years old to 30 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the order of subjects' exposure to 3 different conditions (3 different types of electrical stimulation of the brain) will be randomized by the Latin Squares method. To do so, first using the site www.random.org, a number between 1 and 15 will be randomly allocated to each subject as an identification code. Then, the English letters A, B, and C will be assigned to the three intervention conditions and a Latin Square will be created. In this case, a Latin square with three rows and three columns is created. Finally, participants 1 to 5 will be placed in the sequence of the first row, participants 6 to 10 will be placed in the sequence of the second row, and participants 11 to 15 will be placed in the sequence of the third row.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, the investigator and participants will be blinded to the type and target areas of transcranial electrical stimulation used in each session. In the present study, a Neurostim stimulator will be used to induce direct current electrical stimulation in three separate sessions and in three different modes, including 1) Anodal stimulation of the primary motor cortex (M1), 2) Anodal stimulation of the dorsolateral prefrontal cortex (DLPFC), 3) sham stimulation (Placebo effect). To do so, an individual outside the research team will be responsible for applying electrical stimulation in three test sessions. In order to blind the participants, after they sit on a special chair, the stimulator will be hidden from their view and wrapped by a cover, and the electrodes will be placed on the target areas by that individual. In order to blind the investigator, before the intervention, the investigator leaves the laboratory and returns to the test site after the termination of the stimulation time, removal of the electrodes, and turning off the stimulator. Also, in Sham stimulation mode, according to standard protocols, active current will be applied for 30 seconds in order to induce a feeling similar to active stimulation modes, and then the current is cut off and the stimulation will be deactivated.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Kermanshah Razi University
Street address
Room. 73, Faculty of Sport Sciences, Razi University, University Str, Taq-e-bostan, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2021-12-29, 1400/10/08
Ethics committee reference number
IR.RAZI.REC.1400.023

Health conditions studied

1

Description of health condition studied
The participants are healthy individuals
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Change in anaerobic performance
Timepoint
During and after each bout of 30-seconds Wingate test
Method of measurement
By use of standard 30-seconds Wingate test of lower limb

2

Description
Amplitude of muscle electromyography
Timepoint
During and after each bout of 30-seconds Wingate test of lower limb
Method of measurement
Sixteen channels wireless electromyography device (Noraxon, Scottsdale, AZ85260)

3

Description
Rating of Perceived Exertion
Timepoint
After each bout of 30-seconds Wingate test of lower limb
Method of measurement
By use of 6 to 20 perceived exertion Borg scale

4

Description
Cognitive function
Timepoint
Before and after 3 bouts of 30-seconds Wingate test of lower limb
Method of measurement
by the use of Stroop Color-Word Test

Secondary outcomes

1

Description
Choice reaction time
Timepoint
Before and after 3 bouts of 30-second Wingate test of lower limb
Method of measurement
By the use of Response Panel (63035A, Lafayette, Indiana) reaction time device

2

Description
Pleasure sensation
Timepoint
After each bout of 30-second Wingate test of lower limb
Method of measurement
By the use of 11-item Feel Scale

3

Description
The degree of arousal
Timepoint
After each bout of 30-second Wingate test of lower limb
Method of measurement
By the use of 6-item Felt Arousal Scale

Intervention groups

1

Description
Intervention group: In this study, all subjects will be exposed to two intervention conditions with an interval of at least 72 hours, including 1) anodal electrical brain stimulation of the primary motor cortex, 2) anodal electrical brain stimulation of the dorsolateral prefrontal cortex. In both conditions, the stimulation duration will be 20 minutes and its intensity will be 2 milliamperes. A Neurostim stimulator device made by Medina Teb Company will be used for brain stimulation. Target areas in the brain are identified using the International Brain Mapping 10-20 System. The stimulation of target areas is performed using two special electrodes and a special electroencephalogram (EEG) cap. Under intervention conditions, first, the study variables will be measured and then the subjects will receive brain stimulation. Subjects will then perform 3 bouts of the 30-second Wingate test of the lower limb with 4-minute resting intervals between each bout, and finally, the variables will be re-measured.
Category
Treatment - Devices

2

Description
Control group: In this study, in addition to two intervention sessions, all subjects were exposed to a control session including sham electrical brain stimulation (placebo effect). All details of the control session will be similar to the intervention sessions, except that in the control session, the brain is not electrically stimulated and the electrical current of the stimulator device will be deactivated after 30 seconds. The duration of control conditions will also be 20 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Sport Sciences of Razi University
Full name of responsible person
Mohammad Azizi
Street address
University St, Taq-e-Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3428 3267
Fax
Email
Azizimihammad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Dr. Alireza Zebarjadi
Street address
University St, Taq-e-Bostan
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4515
Email
zebarjadiali@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi 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
Razi University
Full name of responsible person
Ehsan Amiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 73, Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3845 8428
Fax
Email
e.amiri@razi.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University
Full name of responsible person
Ehsan Amiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 73, Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3845 8428
Fax
Email
e.amiri@razi.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Razi University
Full name of responsible person
Ehsan Amiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
No. 73, Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3845 8428
Fax
Email
e.amiri@razi.ac.ir

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 are shared after the de-identification of the participants
When the data will become available and for how long
3 months after publication
To whom data/document is available
All individuals upon formal request
Under which criteria data/document could be used
Data sharing requests are accepted for any purposes
From where data/document is obtainable
To obtain any data/document, please send an e-mail to Ehsan Amiri, a faculty member at Razi University, through the following e-mail address: e.amiri@razi.ac.ir
What processes are involved for a request to access data/document
Upon formal request, mentioning due reasons, and providing full personality details, data will be sent after 72 h via e-mail
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