Protocol summary

Study aim
Comparison of the effects of transcranial direct current and transcranial pulsatile current stimulation on anaerobic performance and neurophysiological responses in basketball girls
Design
A clinical trial with a control group, with a within-group design, reciprocal balance, double-blind, randomized, on 15 subjects. Latin square was used for randomization.
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 will perform the anaerobic test.
Participants/Inclusion and exclusion criteria
Basketball girls with at least two years of club sports experience in the field of basketball Age range from 18 to 30 years A resident of Kermanshah Body mass index (BMI) 18.5 to 24.9 kg/m2 Obtaining a certificate of non-prohibition of participation in sports training program from the doctor
Intervention groups
This study is an intra-group and counterbalanced study, in which subjects are exposed to 3 different conditions of brain stimulation, including: 1) direct anodal stimulation of the left posterior lateral prefrontal cortex, 2) anodal pulse stimulation of the left posterior lateral prefrontal cortex , 3) sham stimulation (placebo effect) will be placed. The duration of stimulation will be 20 minutes and the intensity of direct anodal stimulation will be 2 mA and the intensity of pulse stimulation will be 1.5 mA.
Main outcome variables
Anaerobic peak power, average anaerobic power, fatigue index, EMG amplitude of the quadriceps muscle, pressure perception, pain sensation, heart rate, pleasure sensation, felt arousal sensation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231126060186N1
Registration date: 2023-12-20, 1402/09/29
Registration timing: registered_while_recruiting

Last update: 2023-12-20, 1402/09/29
Update count: 0
Registration date
2023-12-20, 1402/09/29
Registrant information
Name
mastoure salimi
Name of organization / entity
Razi university
Country
Iran (Islamic Republic of)
Phone
+98 83 3429 4268
Email address
mastoure77.salimi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-20, 1402/09/29
Expected recruitment end date
2024-01-05, 1402/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of transcranial direct current and transcranial pulsatile current stimulation on anaerobic performance and neurophysiological responses in basketball girls
Public title
Comparisons of transcranial direct current and transcranial pulsed current motion on anaerobic performance and neurophysiological responses.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Basketball girls with at least two years of experience in club sports in the field of basketball age range 18 to 30 years resident of Kermanshah city body mass index 18.5 to 24.9 weight per square meter certificate of non-prohibition of participation in sports training program from a doctor.
Exclusion criteria:
Suffering from various chronic cardiovascular, pulmonary and metabolic diseases History of seizures, epilepsy or other types of neurological diseases Abnormalities or musculoskeletal disorders 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 brain movement) will be randomized by Latin methods. For this purpose, first, using the www.random.org website, a number between 1 and 15 will be randomly assigned to each of the subjects as an identification code. 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 and the location of stimulation in each session. In the present study, the neurostimulator device was used to induce electrical stimulation of the brain in three separate sessions and three different modes including: 1) direct anodal current stimulation of the left posterior-lateral prefrontal cortex (DLPFC), 2) anodal pulse current stimulation of the posterior cortex - Left lateral prefrontal (DLPFC), 3) sham stimulation (placebo effect) will be used. For this purpose, a person outside the research team will be responsible for applying electrical stimulation during the experimental session. 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
Taghbostan Blvd., Koi 110, in front of No. 54
City
Kermanshah
Province
Kermanshah
Postal code
6714918787
Approval date
2023-10-18, 1402/07/26
Ethics committee reference number
IR.RAZI.REC.1402.068

Health conditions studied

1

Description of health condition studied
Participants are healthy and trained basketball players.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Peak anaerobic power
Timepoint
During the anaerobic test
Method of measurement
Monarch wheel (Monark ergomedic 894E)

2

Description
Average anaerobic power
Timepoint
During the anaerobic test
Method of measurement
Monarch wheel (Monark ergomedic 894E)

3

Description
Fatigue index
Timepoint
During the anaerobic test
Method of measurement
Monarch wheel (Monark ergomedic 894E)

4

Description
Rating of perceived exertion
Timepoint
During the performance of the anaerobic test, during the active recovery period after the performance of the anaerobic test
Method of measurement
Using a pressure perception scale of 6 to 20 borg

5

Description
Amplitude of muscle electromyography
Timepoint
During the performance of the anaerobic test
Method of measurement
16-channel wireless electromyography device (Noraxon model, Scottsdale, AZ85260)

6

Description
feeling pain
Timepoint
During the performance of the anaerobic test, during the active recovery period after the performance of the anaerobic test
Method of measurement
Using a scale of 0 to 10

7

Description
heart beat
Timepoint
During the performance of the anaerobic test, during the active recovery period after the performance of the anaerobic test
Method of measurement
Monarch wheel (Monark ergomedic 894E)

8

Description
sense of pleasure
Timepoint
During the performance of the anaerobic test, during the active recovery period after the performance of the anaerobic test
Method of measurement
Using an 11-item emotion scale

9

Description
Arousal level
Timepoint
During the performance of the anaerobic test, during the active recovery period after the performance of the anaerobic test
Method of measurement
Using a 6-item scale of perceived arousal

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: In this study, all the subjects were exposed to two intervention conditions with an interval of one week, including 1) direct electrical stimulation of the left posterior-lateral prefrontal anodal cortex (DLPFC), 2) electrical pulse electrical stimulation of the posterior-lateral prefrontal anodal cortex. The left frontal (DLPFC) will be located. In both conditions, the duration of stimulation is 20 minutes and the intensity of direct electrical stimulation is 2 milliamperes, and the intensity of pulsed stimulation is 1.5 milliamperes. 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 electrical brain movement in sham mode (placebo effect). All the details of the implementation of the protocol will be similar to the intervention mode, with the difference that in the control mode, electromagnetic is not performed and the electric current of the drive motor is 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
دانشگاه رازی
Full name of responsible person
Mastoure Salimi
Street address
Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
mastoure77.salimi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Farzaneh Ghadami
Street address
Taq Bostan, University Street, Razi University
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
mastoure77.salimi@gmail.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
Vahid Tadibi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Taq Bostan, University Blvd., Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Taq Bostan, University Blvd., Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 9265
Email
vtadibi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Razi University
Full name of responsible person
Mastoure Salimi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Taghbostan Blvd., Koi 110, in front of No. 54
City
Kermanshah
Province
Kermanshah
Postal code
6714918787
Phone
+98 83 3429 4268
Email
mastoure77.salimi@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 the subjects.
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
researchers
Under which criteria data/document could be used
For meta-analysis research
From where data/document is obtainable
If you need to receive documents, send an email to Mastoure Salimi, research researcher, at the email address: mastoure77.salimi@gmail.com.
What processes are involved for a request to access data/document
In case of official request, announcement of the relevant reasons and full details, the data will be sent via email after 72 hours.
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