Protocol summary

Study aim
Comparison the Effects of Single-Site and Dual-Site Transcranial Direct Current Stimulation on Exercise Performance and Psychophysiological Responses in an Endurance Exercise
Design
In the present study, with within-subjects design, counterbalanced and double-blind design, 12 subjects will be randomly exposed to four different conditions.
Settings and conduct
This research will be done in Razi University. After selecting the subjects and familiarizing themselves with the research process, each subject will be exposed to four different conditions of electrical stimulation of the brain with a random combination. Then, the subjects will perform a time trial endurance activity. The principal investigator and subjects will not be aware of the type of stimulation received in each session.
Participants/Inclusion and exclusion criteria
Criteria for entering: Age range from 18 to 35 years. Endurance trained men with a history of at least one year of regular training. No color blindness or color vision disorders. being right-handed Criteria for not entering: Having any cardiovascular, pulmonary and metabolic disease. History of seizures, epilepsy or other types of neurological diseases. The presence of implantable devices or pacemakers in the body. Smoking and alcohol consumption.
Intervention groups
This study is an intra-group and counterbalanced study in which the subjects are exposed to four different conditions of brain stimulation including: 1) anodal stimulation of the primary motor cortex, 2) anodal stimulation of the posterior-lateral prefrontal cortex, 3) two-zone anodal stimulation, 4) sham stimulation (placebo effect) will be placed. Also, the duration of brain stimulation will be 20 minutes and its intensity will be 2 milliamps.
Main outcome variables
change in endurance performance; the degree of perception of pressure; electromyography; cognitive function; reaction time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230729058958N1
Registration date: 2023-08-03, 1402/05/12
Registration timing: prospective

Last update: 2023-08-03, 1402/05/12
Update count: 0
Registration date
2023-08-03, 1402/05/12
Registrant information
Name
Hosna Khoshchehreh
Name of organization / entity
Razi University
Country
Iran (Islamic Republic of)
Phone
+98 83 3432 7161
Email address
h.khoshchehre98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-09-01, 1402/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Single-Site and Dual-Site Transcranial Direct Current Stimulation on Exercise Performance and Psychophysiological Responses of Trained Men in an Endurance Exercise
Public title
Single-Site and Dual-Site Transcranial Direct Current Stimulation and Endurance Exercise
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Endurance trained men with a history of at least one year of regular training. Body mass index (BMI) 18.5 to 24.9 kg per square meter of height. obtaining a certificate of non-prohibition of participating in sports training programs from a doctor. Not suffering from color blindness or color vision disorders. The age range is 18 to 35 years. being right-handed.
Exclusion criteria:
Having any cardiovascular, pulmonary and metabolic disease. History of seizures, epilepsy or other types of neurological diseases. The presence of implantable devices or pacemakers in the body. Smoking and alcohol consumption.
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 12
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 present study, the Neurostim stimulation device was used to induce direct current electrical stimulation in four separate sessions and four different modes including: 1) anodal stimulation of the primary motor cortex, 2) anodal stimulation of the posterior-lateral prefrontal cortex, 3) anodal stimulation of the two regional, 4) sham stimulation (placebo) 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
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Razi University Research Ethics Committee
Street address
Iran, Kermanshah, Taq Bostan, University St., Razi University
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2023-05-10, 1402/02/20
Ethics committee reference number
IR.RAZI.REC.1402.007

Health conditions studied

1

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

Primary outcomes

1

Description
Time gained in time trial endurance performance
Timepoint
After finishing the time trial endurance activity
Method of measurement
Record the time and distance using a bicycle car meter

2

Description
Amplitude of muscle electromyography
Timepoint
Every three kilometers and for 30 seconds
Method of measurement
8-channel wireless electromyography device (model 85260 Noraxon, Scottsdale, AZ)

3

Description
The degree of perception of pressure
Timepoint
Once every three kilometers
Method of measurement
Using a pressure perception scale of 0 to 100 borg

4

Description
Cognitive function
Timepoint
Before and after endurance activity
Method of measurement
Using color-word Stroop test

5

Description
Countdown cognitive test to measure hypofrontality
Timepoint
During the performance of endurance activity in kilometers 4, 8 and 12
Method of measurement
A number from 200 to 300 will be randomly announced by the examinee out loud and the subject will be asked to count out loud for 1 minute in reverse and with a distance of 3 from the announced number.

Secondary outcomes

1

Description
Selective reaction time
Timepoint
Before and after endurance activity
Method of measurement
Using selective reaction time device

2

Description
Pleasure scale
Timepoint
Once every three kilometers
Method of measurement
Using an 11-item emotion scale

3

Description
Arousal scale
Timepoint
Once every three kilometers
Method of measurement
Using a 6-item scale of perceived arousal

4

Description
pain scale
Timepoint
Once every three kilometers
Method of measurement
Using a visual analog scale of 0 to 10

Intervention groups

1

Description
Intervention group: In this study, all the subjects were exposed to all three intervention conditions with an interval of one week, including: 1) anodal stimulation of the primary motor cortex, 2) anodal stimulation of the posterior-lateral prefrontal cortex, 3) bilateral cerebral anodal stimulation. will get In all three conditions, the duration of stimulation will be 20 minutes with an intensity of 2 mA. In order to stimulate, the Neurostim stimulation device manufactured by Medina Teb Company will be used. The target areas in the brain are identified using the 10-20 international brain mapping system, and the target areas are stimulated using special stimulation electrodes and a special electroencephalogram cap.
Category
Treatment - Devices

2

Description
Control group: In this study, in addition to three intervention sessions, all subjects will be exposed to one control session including brain electrical stimulation in sham (placebo) mode. All the details of the implementation of the protocol in the control mode will be similar to the intervention mode, with the difference that in the control mode, the electrical stimulation of the brain is not done and the electrical current of the stimulating device will be deactivated after 30 seconds. The duration of the control condition will be 20 minutes.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Sports Sciences, Razi University
Full name of responsible person
Hosna Khoshchehreh
Street address
Taq Bostan, University Street, Razi University
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
h.khoshchehre98@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Farzaneh Gandomi
Street address
Taq Bostan, University Street, Razi University
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
gandomif@razi.ac.ir
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
Iran, Kermanshah, Taqbestan, University St., Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3845 8428
Email
e.amiri@gmail.com

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
Iran, Kermanshah, Taqbestan, University St., Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3845 8428
Email
e.amiri@razi.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Razi University
Full name of responsible person
Hosna Khoshchehre
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Iran, Kermanshah, Taqbestan, University St., Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
h.khoshchehre98@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 documents, send an email to Hasna Khoshchehre, research researcher, with the email address: h.khoshchehre98@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.
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