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IRCT20260625069942N1 IRCT 2026-07-04 The University of Shahid Beheshti Effect of Cognitive Rehabilitation with tACS on ADHD CRT-tACS-ADHD The Effect of Cognitive Rehabilitation with and without Transcranial Alternating Current Stimulation (tACS) on Improving Neurocognitive and Behavioral Performance in Children with Attention Deficit Hyperactivity Disorder (ADHD) 2025-01-20 anticipated 37 Complete https://irct.ir/trial/91300 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization is performed using simple random sampling method with a table of random numbers generated by SPSS software. The unit of randomization is at the individual level. For allocation concealment, sealed opaque envelopes are used so that the random sequence is generated by an individual independent of the principal investigator, and the envelopes are coded accordingly. After initial assessments, the envelope for each participant is opened, and the individual is assigned to either the experimental group (receiving CRT + active tACS) or the active control group (receiving CRT + sham tACS), Blinding description: In this double-blind study, participants (children and their parents) are unaware of the intervention type (active or sham stimulation). The stimulation device is programmed to deliver the sham protocol in a way that is indistinguishable from active stimulation regarding initial sensation (e.g., mild tingling). Additionally, a trained research assistant, who is blinded to group allocation, is responsible for administering all cognitive tests and completing the questionnaires at pre-test, post-test, and follow-up stages. The principal investigator is aware of the group assignment to adjust the stimulation parameters but is not involved in the outcome assessment or data collection process. N/A Attention-Deficit/Hyperactivity Disorder (ADHD). Intervention 1: Intervention group: 10 sessions of computer-based cognitive rehabilitation using Aram software with active transcranial alternating current stimulation at 40 Hz frequency, 1.5 mA intensity, for 20 minutes per session are performed. Electrodes are placed in a bipolar montage at Fp2 (anode) and F3 (cathode) according to the international 10-20 system. Each session includes three adaptive rule-based cognitive tasks: Go/No-Go, N-Back, and Wisconsin Card Sorting Test. Intervention 2: Control group: 10 sessions of computer-based cognitive rehabilitation using Aram software similar to the experimental group with sham (inactive) transcranial alternating current stimulation are performed. The sham protocol is designed to be indistinguishable from active stimulation regarding initial sensation (mild tingling). Electrodes are placed at the same positions as the experimental group (Fp2 and F3), and participants perform the same three cognitive tasks: Go/No-Go, N-Back, and Wisconsin Card Sorting Test in an adaptive and rule-based manner. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to ethical restrictions and lack of written consent from participants for sharing raw data, there is no plan to make individual participant data available.
public Amir Kaviani Arad
Shahid Shahriari Square, Evin, Shahid Beheshti University, Faculty of Psychology and Educational Sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 29901 a.kavei@mail.sbu.ac.ir The University of Shahid Beheshti scientific Amir Kaviani Arad
Shahid Shahriari Square, Evin, Shahid Beheshti University, Faculty of Psychology and Educational Sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 29901 menelaos.skull@gmail.com The University of Shahid Beheshti Iran (Islamic Republic of) Definitive diagnosis of Attention-Deficit/Hyperactivity Disorder based on structured clinical interview according to DSM-5-TR Age range of 7 to 12 years Normal intelligence quotient based on Raven's test Informed consent from parents and verbal assent from child 7 years 12 years Male Presence of any severe comorbid psychiatric disorder (e.g., psychotic disorder, major depression) History of brain injury or seizure Intellectual disability or mental retardation Use of stimulant medications within 12 hours before assessment or intervention sessions Absence of more than one session from the treatment protocol F90.9 Attention-deficit hyperactivity disorder, unspecified type Rehabilitation Rehabilitation Intervention group: 10 sessions of computer-based cognitive rehabilitation using Aram software with active transcranial alternating current stimulation at 40 Hz frequency, 1.5 mA intensity, for 20 minutes per session are performed. Electrodes are placed in a bipolar montage at Fp2 (anode) and F3 (cathode) according to the international 10-20 system. Each session includes three adaptive rule-based cognitive tasks: Go/No-Go, N-Back, and Wisconsin Card Sorting Test. Control group: 10 sessions of computer-based cognitive rehabilitation using Aram software similar to the experimental group with sham (inactive) transcranial alternating current stimulation are performed. The sham protocol is designed to be indistinguishable from active stimulation regarding initial sensation (mild tingling). Electrodes are placed at the same positions as the experimental group (Fp2 and F3), and participants perform the same three cognitive tasks: Go/No-Go, N-Back, and Wisconsin Card Sorting Test in an adaptive and rule-based manner. Number of commission errors in the Go/No-Go test as an index of inhibitory control. Timepoint: Pre-test, post-test, and one-month follow-up. Method of measurement: Computerized Go/No-Go test. Percentage of correct responses in the N-Back test as an index of working memory. Timepoint: Pre-test, post-test, and one-month follow-up. Method of measurement: Computerized N-Back test. Number of completed categories in the Wisconsin Card Sorting Test as an index of cognitive flexibility. Timepoint: Pre-test, post-test, and one-month follow-up. Method of measurement: Computerized Wisconsin Card Sorting Test. Adjusted score in the Balloon Analogue Risk Task as an index of impulsivity. Timepoint: Pre-test, post-test, and one-month follow-up. Method of measurement: Computerized Balloon Analogue Risk Task. Total score of the Behavior Rating Inventory of Executive Function (parent form) as an index of executive function in daily life. Timepoint: Pre-test, post-test, and one-month follow-up. Method of measurement: Behavior Rating Inventory of Executive Function (parent form). Total score of the Swanson, Nolan and Pelham Questionnaire as an index of core symptoms of attention-deficit/hyperactivity disorder. Timepoint: Pre-test, post-test, and one-month follow-up. Method of measurement: Swanson, Nolan and Pelham Questionnaire. The University of Shahid Beheshti Approved 2025-06-07 Research Ethics Committee of Shahid Beheshti University Shahid Beheshti University, Presidential Building, Research Deputy, Office of the Research Ethics Committee, Shahid Shahriari Square, Evin, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)