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IRCT20180723040567N2 IRCT 2023-06-04 Mashhad University of Medical Sciences The effect of Transcranial Direct Current Stimulation(TDCS)on cognitive problems in children and adolescents with ADHD The effect of Transcranial Direct Current Stimulation(TDCS)on cognitive problems in children and adolescents with attention deficit hyperactivity disorder 2022-12-06 anticipated 44 Complete https://irct.ir/trial/69369 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For the random allocation of cases to two groups A and B according to the number of interventions, blocks of four were considered. By using the sealed envelope site, blocks were created and a random sequence of blocks was created. The sequence created is shown below. created were assigned to the groups. A closed envelope was used to hide the allocation. After entering the plan and signing the consent form, the patients received the envelope and went to the clinic to perform the test. Only the person performing the test of the type of test Done was aware. Block sizes: 4 Actual list length: 44 block identifier, block size, sequence within block, treatment, Blinding description: The study is a two-way blind study, the shape of the device, the intensity of the applied current and the duration are the same in both tDCS and sham groups. The patient and their clinical caregiver and the analysts are not aware of what treatment they have undergone and the intervention of tDCS or The sham is applied with the help of the project's associate psychologist. 3 Attention- Deficit Hyperactivity Disorders. Intervention 1: Intervention group: each session of tDCS with an intensity of 1 milliamp and a duration of 20 minutes, 2 to 3 times a week for 5 weeks. Intervention 2: Control group: Each session of sham tDCS for 20 minutes, 2 to 3 times a week during 5 weeks. Yes - There is a plan to make this available What will be shared: The total individual participants' data and the results of the study after the deidentification of the individuals are shared. When: starting in march 2023 To whom: All researchers are able to access the study results Conditions: Unidentifiable information is not shared with another organization Where to obtain: Unidentifiable information is not available to applicants How to obtain: Study data is published in the course of the paper and no other personal data is available to applicants Comments:
public Fatemeh Mohareri
Ebne-sina hospital , Horre Ameli Avenue,
Mashhad Iran (Islamic Republic of) 9195983134 +98 51 3700 2301 Moharerif1@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Mohareri
Ebne-sina hospital , Horre Ameli Avenue,
Mashhsd Iran (Islamic Republic of) 9195983134 +98 51 3700 2301 Moharerif1@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Diagnosis of ADHD based on DSM-5 criteria aged 7-18 years Normal IQ >=80 Complete consent form by parent or guardian Absence of other psychiatric disorders Cooperation compliance in parent and child-adolescent 7 years 18 years Both Presence of other medical or psychiatric disorders Having a history of seizures Deformity in the face or skull Having a pacemaker History of receiving ECT History of receiving tDCS F90 Attention-deficit hyperactivity disorders Treatment - Devices Placebo Intervention group: each session of tDCS with an intensity of 1 milliamp and a duration of 20 minutes, 2 to 3 times a week for 5 weeks Control group: Each session of sham tDCS for 20 minutes, 2 to 3 times a week during 5 weeks Working memory problems in children and adolescents with ADHD. Timepoint: Before the first session of tDCS and sham, and after the last session of tDCS and sham. Method of measurement: Forward and reverse digit span test. Selective attention problems in children and adolescents with ADHD. Timepoint: Before the first session of tDCS and sham, and after the last session of tDCS and sham. Method of measurement: stroop test. Executive function problems in children and adolescents with ADHD. Timepoint: Before the first session of tDCS and sham, and after the last session of tDCS and sham. Method of measurement: n-Back test. Mashhad University of Medical Sciences Approved 2023-02-03 Ethics committee of Mashhad University of Medical sciences Ghoreishi Department, Daneshgah Ave Mashhad Razavi Khorasan Iran (Islamic Republic of)