Protocol summary
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Study aim
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Determining the effect of transcranial direct electrical stimulation on cognitive function in children with attention deficit hyperactivity disorder
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Design
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Clinical trial with control group with two groups only without blinding randomized on 37 patients. Randomized by a table of random numbers
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Settings and conduct
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This study will be conducted as a clinical trial in 22 Bahman clinic in 2023. Each of the members of the two groups will be individually pre-tested using the Swanson-Nolan and Pelham questionnaire, the audio-visual continuous assessment software (IVA-2).The method of applying stimulation in tDCS will be in such a way that the sponge pad, which is actually the covering of the electrodes, will be soaked with 3% sodium chloride and the electrodes will be placed inside it. Anode tDCS stimulation with an intensity of 2 mA for 21 minutes and in ten sessions will be performed on the experimental group. One group received standard treatment and the other group received tdcs in addition to standard treatment, and the post-test will be performed on all participants.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1- Children under 12 years old
3- Willingness to study
Conditions of non-entry of participants:
1- Unwillingness to participate in the study
2-Suffering from another psychiatric disorder
3- The presence of metal parts in the body
4- Seizure history
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Intervention groups
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This study will be conducted as a clinical trial on children with attention deficit hyperactivity disorder. One group will receive the standard treatment and one group will receive the tdcs method in addition to the standard treatment
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Main outcome variables
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Short term memory; Visual and spatial skills; Executive functions; Attention and concentration; Language; Awareness of time and place; Direct electrical stimulation
General information
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Reason for update
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Changing the sample size.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20231030059908N1
Registration date:
2023-11-21, 1402/08/30
Registration timing:
registered_while_recruiting
Last update:
2025-02-22, 1403/12/04
Update count:
1
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Registration date
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2023-11-21, 1402/08/30
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-12-01, 1402/09/10
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Expected recruitment end date
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2024-05-30, 1403/03/10
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Actual recruitment start date
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2023-09-23, 1402/07/01
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Actual recruitment end date
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2025-01-18, 1403/10/29
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Trial completion date
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2025-01-18, 1403/10/29
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Scientific title
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Investigating the effectiveness of transcranial direct electrical stimulation cognitive functions in children with attention deficit hyperactivity disorder
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Public title
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Investigation the Effect of transcranial Direct Current Stimulation (TDCS) in attention-deficit, hyperactivity disorder (ADHD)
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
ADHD
Exclusion criteria:
Unwilling to participate in the study
Having another psychiatric disorder
The presence of metal grafts in the body
History of seizures
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Age
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From 6 years old to 12 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
64
Actual sample size reached:
34
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization is using a table of random numbers that are selected through a random number computer.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-07-19, 1402/04/28
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Ethics committee reference number
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IR.IAU.MSHD.REC.1402.045
Health conditions studied
1
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Description of health condition studied
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ADHD
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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The score of Swanson-Nolan and Pelham questionnaire (SNAP_4)
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Timepoint
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The beginning of the study 30 days after the start of the study
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Method of measurement
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Swanson-Nolan and Pelham questionnaire
2
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Description
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Cognitive assessment
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Timepoint
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The first day before the start, the tenth day.
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Method of measurement
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IVA-2 cognitive assessment software
Intervention groups
1
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Description
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Intervention group: receiving transcranial direct stimulation for 21 minutes in 10 sessions
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Category
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Treatment - Devices
2
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Description
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Intervention group: In addition to the standard treatment, the new treatment receives transcranial direct electrical stimulation
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Islamic Azad University
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available