Protocol summary

Study aim
Determining the effect of bilateral stimulation of direct current and transcranial pulsed current on muscle and cognitive function, and neurophysiological responses in submaximal isotonic contractions
Design
A study with a within-group design, cross-balanced and double-blind. 15 subjects will be randomly exposed to 3 different conditions. In order to randomize the conditions, the website www.randomization.com will be used.
Settings and conduct
This study will be done in Razi University. After selecting the subjects and familiarizing themselves with the research process, each subject will be exposed to 3 different conditions of electrical stimulation of the brain in a random order, and then, they will perform three bouts of resistance activity until they reach exhaustion.
Participants/Inclusion and exclusion criteria
Criteria for entering the research: - Age range from 18 to 30 years - Women with a history of regular resistance exercises - Body mass index (BMI) 18.5 to 24.9 kilograms per square meter of height - Has natural vision for color recognition - Being right-handed (the dominant hand should be the right hand) Criteria for not entering the research: - Suffering from any cardiovascular, pulmonary and metabolic disease - History of seizures, epilepsy or other types of neurological diseases - Presence of implantable devices or pacemakers in the body - Smoking and alcohol consumption
Intervention groups
This study is an intra-group and counterbalanced study, and subjects will be exposed to 3 different conditions of brain stimulation including: 1) direct current anodal stimulation, 2) pulse current anodal stimulation, 3) sham stimulation (placebo effect) . The duration of stimulation will be 20 minutes and its intensity will be 2 mA.
Main outcome variables
Muscle function, electromyography, pressure perception, cognitive and perceptual function

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240424061556N1
Registration date: 2024-05-04, 1403/02/15
Registration timing: prospective

Last update: 2024-05-04, 1403/02/15
Update count: 0
Registration date
2024-05-04, 1403/02/15
Registrant information
Name
Zahra Seyfi
Name of organization / entity
Razi University of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 4823 0281
Email address
zahraseyfi6213@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-14, 1403/02/25
Expected recruitment end date
2024-05-30, 1403/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Dual-Site Transcranial Direct Current and Pulsed Current Stimulation on Muscular Performance and Neurophysiological Responses in Submaximal Isotonic Contractions
Public title
Comparison of Effect of Dual-Site Transcranial Direct Current and Pulsed Current Stimulation on submaximal Isotonic contractions
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 18 to 30 years Women with more than 6 months of regular resistance training Body mass index (BMI) 18.5 to 24.9 kg/squared height in meters Has natural color vision Being right-handed (the dominant hand should be the right hand)
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 30 years old
Gender
Female
Phase
3
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 subject exposure to 3 different conditions (3 different types of electrical stimulation of the brain) will be randomized by the Latin square method. For this purpose, a number between 1 and 15 will be randomly assigned to each of the subjects as an identification code using www.random.org. Then, the English letters B, A 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 number 1 to 5 are placed in the sequence of the first row, participants number 6 to 10 are placed in the sequence of the second row, and participants number 11 to 15 are placed in the sequence of the third row.
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 in each session. In this study, the Neurostim stimulation device will be used to induce direct current electrical stimulation in three separate sessions and three different modes including: 1) direct current anodal stimulation, 2) pulsed current anodal stimulation, 3) sham stimulation (placebo effect) became. For this purpose, a person 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 stimulating device is hidden from their sight and is completely covered by a cover, and the electrodes are 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 sham stimulation mode, according to standard protocols, active current is induced on the head for 30 seconds in order to induce the same sensation as in 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
Ethics Committee of Razi University of Kermanshah
Street address
Street Address Iran, Kermanshah, Taq Bostan, University St., Razi University, Faculty of Sports Sciences, Room 73
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2024-03-06, 1402/12/16
Ethics committee reference number
IR.RAZI.REC.1403.002

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
Muscle performance
Timepoint
After each set of resistance training with 50% 1RM in three sets
Method of measurement
Number of repetitions in each set × The weight has shifted

2

Description
Rating of Perceived Exertion
Timepoint
At the end of each set
Method of measurement
Using a scale of 0 to 100 borg

Secondary outcomes

1

Description
Inhibitory control
Timepoint
Before and after the residual resistance protocol
Method of measurement
Modified Stroop test software

2

Description
Choice reaction time
Timepoint
Before and after the residual resistance protocol
Method of measurement
Selective reaction timer test software

3

Description
Pleasure scale
Timepoint
At the end of each set
Method of measurement
Using a 11-item emotion scale

4

Description
Pleasure Arousal scale
Timepoint
At the end of each set
Method of measurement
Using a 6-item pleasure Arousal scale

5

Description
Pain scale
Timepoint
At the end of each set
Method of measurement
Using a 10-item pain scale

Intervention groups

1

Description
Intervention group: In this study, all subjects will be exposed to two intervention conditions with a minimum interval of 72 hours, including 1) two-zone direct current electrical stimulation, 2) two-zone pulse current electrical stimulation. In both conditions, the duration of stimulation will be 20 minutes and its intensity will be 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 international brain mapping system 10-20, and the target areas are stimulated using two special stimulation electrodes and a special electroencephalogram cap.
Category
Treatment - Devices

2

Description
Control group: In this research, in addition to two intervention sessions, all subjects are exposed to a control session including brain electrical stimulation in a sham state (placebo effect). 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
Zahra Seyfi
Street address
Taq Bostan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
zahraseyfi6213@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi university of Kermanshah
Full name of responsible person
Mostafa Mostafaei
Street address
Taq Bostan, University Street
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4515
Email
b.mostafaei@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 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
Ehsan Amiri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Taq Bostan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4585
Email
e.amiri@razi.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi university of Kermanshah
Full name of responsible person
Ehsan Amiri
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Taq Bostan, University Street, Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4585
Email
e.amiri@razi.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Razi university of Kermanshah
Full name of responsible person
Zahra Seyfi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
No. 23, No. 23, Ghazali Street, 45 Meter Second St., 17 Meter St., Hafiziyah
City
Kermanshah
Province
Kermanshah
Postal code
6715839548
Phone
+98 83 3832 5860
Email
zahraseyfi6213@yahoo.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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared after de-identifying the subjects.
When the data will become available and for how long
6-9 months after printing the results
To whom data/document is available
Head of the research team and executive researcher
Under which criteria data/document could be used
Meta-analysis
From where data/document is obtainable
If you need to receive documents, please send an email to Ehsan Amiri, head of research, at e.amiri@razi.ac.ir and Zahra Sayifi, lead researcher, at zahraseyfi6213@yahoo.com.
What processes are involved for a request to access data/document
In case of an official request, the relevant reasons are announced and full details are mentioned, the data will be sent via email after 72 hours.
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