Comparing the Effect of Methylphenidate and Anodal tDCS on Inhibitory Control and Working-Memory in Children and Adolescents with Attention Deficit/Hyperactivity Disorder: A Study Protocol for a Randomized, within-Subject Trial
Abstract
:1. Introduction
Research Objectives
- Investigating whether one session of anodal tDCS over left DLPFC will improve inhibitory control compared to placebo condition (sham tDCS) and to MPH;
- Exploring whether one session of anodal tDCS over left DLPFC will enhance WM compared to placebo condition (sham tDCS) and to MPH.
2. Materials and Methods
2.1. Ethical Committee
2.2. Participants
2.3. Study Design
2.4. Interventions
2.4.1. Transcranial Direct Current Stimulation
2.4.2. Methylphenidate
2.5. Clinical Eligibility Assessment
- -
- Mild, when few symptoms beyond the required number for diagnosis are present, and symptoms result in minor impairment in social, school, or work settings;
- -
- Moderate, when symptoms or functional impairment between “mild” and “severe” are present;
- -
- Severe, when many symptoms are present beyond the number needed to make a diagnosis, and result in marked impairment in social, school, or work settings.
2.5.1. K-SADS- PL DSM-5: The Semi-Structured Interview
2.5.2. Children Global Assessment Scale
2.5.3. SNAP-IV
2.5.4. Child Behavior Checklist
2.5.5. Conners’ Rating Scales—Italian Adaptation
2.5.6. Adaptive Behavior Assessment System
2.5.7. Non-Verbal Intelligence Quotient
2.6. Outcome Measures
2.6.1. Stop Signal Task
2.6.2. Visual-Spatial N-Back Task
2.7. Safety Procedures
2.7.1. Safety and Tolerability of tDCS
2.7.2. Safety and Tolerability of MPH
2.7.3. Informed Consent and Data Treatments
2.7.4. Protection of Risks
2.7.5. Missed Sessions and Early Termination of Participation
2.7.6. Study Monitoring and Data Management
2.8. Power and Sample Size Considerations
3. Data Analyses and Expected Results
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Acknowledgments
Conflicts of Interest
References
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D’Aiello, B.; Battisti, A.; Lazzaro, G.; Pani, P.; De Rossi, P.; Di Vara, S.; Pretelli, I.; Costanzo, F.; Vicari, S.; Menghini, D. Comparing the Effect of Methylphenidate and Anodal tDCS on Inhibitory Control and Working-Memory in Children and Adolescents with Attention Deficit/Hyperactivity Disorder: A Study Protocol for a Randomized, within-Subject Trial. Int. J. Environ. Res. Public Health 2022, 19, 4575. https://doi.org/10.3390/ijerph19084575
D’Aiello B, Battisti A, Lazzaro G, Pani P, De Rossi P, Di Vara S, Pretelli I, Costanzo F, Vicari S, Menghini D. Comparing the Effect of Methylphenidate and Anodal tDCS on Inhibitory Control and Working-Memory in Children and Adolescents with Attention Deficit/Hyperactivity Disorder: A Study Protocol for a Randomized, within-Subject Trial. International Journal of Environmental Research and Public Health. 2022; 19(8):4575. https://doi.org/10.3390/ijerph19084575
Chicago/Turabian StyleD’Aiello, Barbara, Andrea Battisti, Giulia Lazzaro, Pierpaolo Pani, Pietro De Rossi, Silvia Di Vara, Italo Pretelli, Floriana Costanzo, Stefano Vicari, and Deny Menghini. 2022. "Comparing the Effect of Methylphenidate and Anodal tDCS on Inhibitory Control and Working-Memory in Children and Adolescents with Attention Deficit/Hyperactivity Disorder: A Study Protocol for a Randomized, within-Subject Trial" International Journal of Environmental Research and Public Health 19, no. 8: 4575. https://doi.org/10.3390/ijerph19084575