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Effectiveness of tDCS with and without binaural beats on working memory, sustained attention and inhibitory response: a clinical trial study

Protocol summary

Study aim
The aim of the present research is to investigate the effectiveness of tDCS stimulation with and without binaural beat on working memory, sustained attention, and inhibitory response.
Design
The study is performed on 45 healthy adults in three groups of experimental and sham. All subjects will be randomly selected in each of the groups based on purposive sampling.
Settings and conduct
The participants in this research will be familiar with the research through the call that will be arranged. Then, after conducting a structured clinical interview by a clinical psychologist, the volunteers will be evaluated according to the entry and exit criteria. At first, people will be evaluated by purposeful sampling to check the criteria, and then people will be randomly assigned to test and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:All students studying at Kurdistan University in 2024-2025, aged 20-35, with healthy hearing, right-handedness, and no psychiatric disorders.Not taking psychiatric drugs. Exclusion criteria: not tolerating the stimulation of binaural beats and tDCS, absence in two sessions of treatment, unwillingness to continue treatment.
Intervention groups
Participants will be assigned to the three groups including tDCS, tDCS with binaural beat, and control groups
Main outcome variables
Changes in working memory functions, sustained attention,Inhibitory response

General information

Reason for update
Acronym
tDCS & binaural beats
IRCT registration information
IRCT registration number: IRCT20231127060202N1
Registration date: 2024-05-31, 1403/03/11
Registration timing: registered_while_recruiting

Last update: 2024-05-31, 1403/03/11
Update count: 0
Registration date
2024-05-31, 1403/03/11
Registrant information
Name
Alireza Karimi
Name of organization / entity
The University of kurdistan
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 4600
Email address
alireza.karimi@uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of tDCS with and without binaural beats on working memory, sustained attention and inhibitory response: a clinical trial study
Public title
Effectiveness of tDCS with and without binaural beats
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Hearing health Being right-handed Not having a mental-neurological disorder Absence of psychiatric disorders Not taking psychiatric drugs Failure to receive any psychological and neuropsychological intervention at the same time as the research Absence of brain injuries and diseases, including epilepsy
Exclusion criteria:
Intolerance of binaural beats stimulation Occurrence of headache on different days of stimulation with tDCS Absence in two sessions of treatment Reluctance to continue treatment
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
After the participants are selected based on the entry and exit criteria, they will be placed in the treatment and control groups using the minimization method. The purpose of this method is to control gender variable. So if the first participant be female, she will assigne in group number one. When the second participant be a man, he will assigne in the first group. When the third participant be female, she will assigne to the second group. If the fourth participant be female, she will assigne to third group and then the rest of the participants will place in the groups by adjusting the gender variable.
Blinding (investigator's opinion)
Double blinded
Blinding description
Interviews will conduct by an expert clinical therapist to assess the inclusion and exclusion criteria. After that, individuals randomly will assign to treatment groups (tDCS group and binaural beats + tDCS group) and wait- list group. Allocation of participants, will administer by someone other than therapist.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in biomedical research
Street address
Pasdaran Blvd., University of Kurdistan., Central organization
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Approval date
2024-04-13, 1403/01/25
Ethics committee reference number
IR.UOK.REC.1403.001

Health conditions studied

1

Description of health condition studied
working memory, sustained attention and inhibitory response
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Score of working memory from n-back test
Timepoint
before intervention; After the intervention; 1 month after the intervention
Method of measurement
N- back software

2

Description
Score of Sustained attention from CPT test
Timepoint
before intervention; After the intervention; 1 month after the intervention
Method of measurement
CPT software

3

Description
Score of inhibition response from go/no go test
Timepoint
before intervention; After the intervention; 1 month after the intervention
Method of measurement
Go/no go software

4

Description
Score of Auditory working memory from PASAT test
Timepoint
before intervention; After the intervention; 1 month after the intervention
Method of measurement
PASAT software

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The group receiving tDCS will have the anode electrode in the F4 area and the cathode electrode in the FP1 area based on the scoring system. 35 square cm electrodes will be used. The current intensity of 2 milliamps is applied for 30 minutes. The treatment sessions will be done consecutively during two weeks, except for 2 days on the weekend, for 10 days.
Category
Treatment - Devices

2

Description
Intervention group: In the group receiving tDCS + binaural beat wave stimulation, the tDCS stimulation will be similar to the previous group and the protocol used for this binaural beat wave stimulation is the use of beta waves in the range of 15 Hz, which is applied by headphones. The duration of binaural beat stimulation is 30 Minutes will be done in two weeks consecutively, except for 2 days on the weekend for 10 days.
Category
Treatment - Devices

3

Description
Control group: In the control group, the subjects received the same protocols, but the stimulation in these people is done in a different way, so that in both the experimental and placebo studies, the stimulation is done up to 2 milliamps, but the difference is that in the experimental study, this stimulation is done after 30 The minute is automatically turned off, but in the placebo study, the stimulation is stopped after 30 seconds. Individuals in this group will not receive any binaural beat intervention. The time and method of execution are similar to the previous groups.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Counselling center of University of Kurdistan
Full name of responsible person
Mehdi Zemestani
Street address
Pasdaran Blvd., University of Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
+98 87 3366 6746
Email
m.zemestan@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Kurdistan
Full name of responsible person
Ali Akbar Mozafari
Street address
Pasdarsn Blvd; University of Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
info@uok.ac.ir
Phone
+98 87 3362 7722
Email
a.mozafari@uok.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Kurdistan
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
University of Kurdistan
Full name of responsible person
Alireza karimi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Cognitive psychology
Street address
Pasdaran Blvd; University of Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
087-33664600-8
Email
alireza.karimi@uok.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Farzad Nasiri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Pasdaran Blvd; University of Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
087-33664601-2246
Email
nasiri.uok@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of Kurdistan
Full name of responsible person
Alireza karimi
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Cognitive psychology
Street address
Pasdaran Blvd; University of Kurdistan
City
Sanandaj
Province
Kurdistan
Postal code
66177-15175
Phone
087-33664600-8
Email
alireza.karimi@uok.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data including information about the main consequence can be shared.
When the data will become available and for how long
Start of accessibility will be one year after printing the results.
To whom data/document is available
Data will only be available to researchers working in academic institutions.
Under which criteria data/document could be used
Requests for data are only permitted for intercultural studies or the studies of meta-analysis.
From where data/document is obtainable
Researchers can use the mentioned communication channel to receive the desired documents or data. Email: nasiri.uok@yahoo.com
What processes are involved for a request to access data/document
Data will be provided by email or post after evaluation of the request.
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