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IRCT20260718070240N1 IRCT 2026-08-17 Shahid Beheshti University Effect of Anodal Transcranial Direct Current Stimulation on Executive Functions in Children with Congenital Heart Disease The Effectiveness of Anodal Transcranial Direct Current Stimulation (tDCS) over the Dorsolateral Prefrontal Cortex (DLPFC) on Executive Functions in Children with Congenital Heart Disease 2026-08-23 anticipated 40 Complete https://irct.ir/trial/91764 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Single, Purpose: Treatment, Randomization description: After confirmation of eligibility and completion of the baseline assessments, participants will be randomly assigned in a 1:1 ratio to either the active transcranial direct current stimulation group or the sham stimulation control group. Block randomization will be performed using Random Allocation Software, Blinding description: Participants will be blinded to whether they receive active or sham transcranial direct current stimulation. The pre-intervention, post-intervention, and six-week follow-up assessments will be conducted by a research colleague who will be unaware of the participants’ group allocation. Therefore, both the participants and the outcome assessor will remain blinded throughout the study. N/A Congenital Heart Disease (CHD). Intervention 1: Intervention group: Participants in this group will receive active transcranial direct current stimulation using the NeuroStim 2 device manufactured by Medina Teb Company. Stimulation will be administered at a current intensity of 1.5 milliamperes for 20 minutes per session, using 5 × 5-centimeter electrodes. The anode will be placed over the F3 position, corresponding to the left dorsolateral prefrontal cortex, and the cathode will be placed over the right shoulder. The intervention will consist of 10 sessions over a four-week period, with three sessions per week and an interval of at least one day between sessions. Before stimulation, the electrode placement sites will be prepared and electrode impedance will be checked. All sessions will be administered by trained personnel in accordance with relevant safety considerations. Intervention 2: Control group: Control group: Participants in this group will receive sham transcranial direct current stimulation using the NeuroStim 2 device manufactured by Medina Teb Company. The 5 × 5-centimeter electrodes will be positioned in the same manner as in the intervention group, with the anode placed over the F3 position, corresponding to the left dorsolateral prefrontal cortex, and the cathode placed over the right shoulder. At the beginning of each session, the current intensity will be gradually increased to 1.5 milliamperes over approximately 30 seconds to produce an initial tingling sensation similar to active stimulation. The current will then be gradually reduced over approximately 30 seconds, and no effective current will be delivered during the remainder of the session. The duration of attendance, preparation procedures, electrode placement, and impedance monitoring will be identical to those of the intervention group. Sham stimulation will be administered in 10 sessions over a four-week period, with three sessions per week and an interval of at least one day between sessions. After completion of all study assessments, participants in the control group will be offered five free sessions of active stimulation for ethical considerations. Yes - There is a plan to make this available What will be shared: De-identified individual participant data and related study documents. After publication of the main study results, de-identified participant-level data on demographic and clinical characteristics, group allocation, executive function outcomes, and adverse events, together with the study protocol and data collection forms, may be shared with qualified researchers upon reasonable request and after approval by the principal investigator and compliance with the relevant ethics requirements. No direct identifiers or information that could reasonably permit identification of participants will be shared. When: Access to the research data and related documents will begin six months after the publication of the main study results and will remain available indefinitely. To whom: Qualified researchers affiliated with recognized universities, scientific and research institutions, or healthcare centers may submit a request to access the study data or related documents. Access will be granted upon submission of a written request, a valid research proposal, ethics committee approval, and a signed data confidentiality agreement. Researchers employed in industry may apply only if they are formally collaborating with a recognized academic or research institution and meet the aforementioned requirements. Conditions: The research data and related documents may only be used for scientific and research purposes, including statistical analyses, secondary data analyses, and validation of the study findings. The provided data will be shared in a de-identified format, and any commercial use, transfer of data to third parties, or attempts to re-identify participants will be prohibited. Data access will be subject to submission of a formal request, a description of the intended purpose and analysis methods, verification of the applicant’s scientific qualifications, ethical approval when required, and agreement to maintain confidentiality and ensure responsible use of the data. Where to obtain: Applicants seeking access to the research data or related documents should first submit a formal request by email to Ms. Yasaman Sadat Tabatabaei, the principal researcher, at y.tabatabaei@mail.sbu.ac.ir. The request should include the applicant’s full details, academic or institutional affiliation, the intended purpose of data use, a brief description of the proposed research, and the planned analytical methods. When necessary, requests will be reviewed in coordination with the study supervisors, Dr. Vahid Sadeghi Firoozabadi and Dr. Vahid Nejati, and the study advisor, Dr. Ehsan Aghaei Moghadam. Institutional inquiries concerning clinical data or study documents may also be directed to the Heart Research Center affiliated with Tehran University of Medical Sciences. Data or documents will be provided only after approval of the request, compliance with ethical requirements, and completion of a confidentiality agreement. How to obtain: Applicants must submit a formal request by email to the principal researcher. The request should include the applicant’s identity and institutional affiliation, the intended purpose of using the data or documents, a brief description of the proposed research, the planned analytical methods, and ethics committee approval when required. Receipt of the request will be acknowledged within a maximum of five working days. The request will then be reviewed for scientific merit, ethical compliance, feasibility, and consistency with the participants’ informed consent. This review will be conducted by the principal researcher and, when necessary, in coordination with the study supervisors and the relevant research center. The review process will normally take between 10 and 15 working days. Following preliminary approval, the applicant will be required to sign a confidentiality and responsible data-use agreement and provide any additional documents, if necessary. Once all requirements have been fulfilled, the approved de-identified data or study documents will be securely provided within a maximum of 10 working days. Overall, when the request and supporting documents are complete, the process is expected to take approximately three to six weeks. Incomplete requests or applications requiring additional ethical or institutional review may take longer Comments:
public Yasaman Sadat Tabatabaei
Shahid Shahriari Square, Evin, Tehran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 8841 8743 yasamantabatabaei79@gmail.com Faculty of Psychology and Educational Sciences, Shahid Beheshti University scientific Yasaman Sadat Tabatabaei
Shahid Shahriari Square, Evin, Tehran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 8841 8743 yasamantabatabaei79@gmail.com Faculty of Psychology and Educational Sciences, Shahid Beheshti University Iran (Islamic Republic of) Iran (Islamic Republic of) Right-handedness Absence of moderate to severe intellectual disability or cognitive impairment, with sufficient ability to understand the instructions and actively participate in the cognitive tasks, based on clinical interview and parental report No history of neurological complications during or immediately after cardiac surgery, based on the medical records Provision of written informed consent by the parent or legal guardian and assent from the child to participate in the research. 8 years 15 years Both Receiving any type of brain electrical stimulation (including tDCS) or concurrent psychiatric interventions. History of epilepsy and seizures, or comorbid genetic syndromes such as Down syndrome, Williams syndrome, and DiGeorge syndrome. Changes in the dosage of psychiatric medications within the past month, or the use of medications that affect seizure threshold. Presence of non-removable intracranial or intraoral implants, as well as a history of surgery in the head region. Treatment - Devices Treatment - Devices Intervention group: Participants in this group will receive active transcranial direct current stimulation using the NeuroStim 2 device manufactured by Medina Teb Company. Stimulation will be administered at a current intensity of 1.5 milliamperes for 20 minutes per session, using 5 × 5-centimeter electrodes. The anode will be placed over the F3 position, corresponding to the left dorsolateral prefrontal cortex, and the cathode will be placed over the right shoulder. The intervention will consist of 10 sessions over a four-week period, with three sessions per week and an interval of at least one day between sessions. Before stimulation, the electrode placement sites will be prepared and electrode impedance will be checked. All sessions will be administered by trained personnel in accordance with relevant safety considerations. Control group: Control group: Participants in this group will receive sham transcranial direct current stimulation using the NeuroStim 2 device manufactured by Medina Teb Company. The 5 × 5-centimeter electrodes will be positioned in the same manner as in the intervention group, with the anode placed over the F3 position, corresponding to the left dorsolateral prefrontal cortex, and the cathode placed over the right shoulder. At the beginning of each session, the current intensity will be gradually increased to 1.5 milliamperes over approximately 30 seconds to produce an initial tingling sensation similar to active stimulation. The current will then be gradually reduced over approximately 30 seconds, and no effective current will be delivered during the remainder of the session. The duration of attendance, preparation procedures, electrode placement, and impedance monitoring will be identical to those of the intervention group. Sham stimulation will be administered in 10 sessions over a four-week period, with three sessions per week and an interval of at least one day between sessions. After completion of all study assessments, participants in the control group will be offered five free sessions of active stimulation for ethical considerations. Cognitive flexibility will be assessed using the Intra-Extra Dimensional Set Shift task (IED) and the Attention Switching Task (AST) of the CANTAB. The main outcome measures will include the adjusted total errors and extra-dimensional shift errors in the IED, as well as switching cost in the AST. Reductions in errors and switching cost at the post-intervention and follow-up assessments compared with baseline will indicate improved cognitive flexibility. Timepoint: Measurements will be conducted at three time points: pre-test before the intervention, post-test immediately after completion of the intervention, and a one-month follow-up after completion of the intervention. Method of measurement: Cognitive flexibility will be measured using the Intra-Extra Dimensional Set Shift task and the Attention Switching Task from the Cambridge Neuropsychological Test Automated Battery. Working memory will be assessed using the Spatial Span task (SSP) and the Spatial Working Memory task (SWM) of the CANTAB. Spatial span in the SSP will be used as an indicator of visuospatial short-term memory capacity, and between-search errors in the SWM will be used as an indicator of spatial working-memory performance. An increase in spatial span and a reduction in between-search errors at the post-intervention and follow-up assessments compared with baseline will indicate improved working memory. Timepoint: Measurements will be conducted at three time points: pre-test before the intervention, post-test immediately after completion of the intervention, and a one-month follow-up after completion of the intervention. Method of measurement: Working memory will be measured using the Spatial Span task and the Spatial Working Memory task from the Cambridge Neuropsychological Test Automated Battery. Sustained attention will be assessed using the Rapid Visual Information Processing task (RVP) of the CANTAB. The A′ score will be used as an indicator of sensitivity to target stimuli, and mean response latency will be used as an indicator of response speed. An increase in the A′ score and a reduction in response latency at the post-intervention and follow-up assessments compared with baseline will indicate improved sustained attention. Timepoint: Measurements will be conducted at three time points: pre-test before the intervention, post-test immediately after completion of the intervention, and a one-month follow-up after completion of the intervention. Method of measurement: Sustained attention will be measured using the Rapid Visual Information Processing task from the Cambridge Neuropsychological Test Automated Battery. Response inhibition will be assessed using the Affective Go/No-Go task (AGN) and the Stop Signal Task (SST) of the CANTAB. Total commission errors in the AGN and Stop-Signal Reaction Time in the SST will be considered the main indicators of response-inhibition performance. Reductions in commission errors and Stop-Signal Reaction Time at the post-intervention and follow-up assessments compared with baseline will indicate improved response inhibition. Timepoint: Measurements will be conducted at three time points: pre-test before the intervention, post-test immediately after completion of the intervention, and a one-month follow-up after completion of the intervention. Method of measurement: Response inhibition will be measured using the Affective Go/No-Go task and the Stop Signal Task from the Cambridge Neuropsychological Test Automated Battery. Shahid Beheshti University Approved 2026-05-23 Research Ethics Committees of Shahid Beheshti University Shahid Shahriari Square, Evin Tehran Tehran Iran (Islamic Republic of)