Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

What this Trial Is About

Attention Deficit Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder in children characterized by symptoms of inattention, impulsivity, and hyperactivity that affect learning, social life, and daily activities. This research aims to evaluate the effects of Transcranial Direct Current Stimulation (tDCS), a safe and non-invasive brain stimulation technique, combined with cognitive training exercises on reducing ADHD symptoms in children aged 7 to 14 years. The study is a Phase 3 clinical trial focusing on children diagnosed with combined presentation ADHD according to DSM-5 criteria. Children participating in the study will be randomly assigned to receive either real tDCS or a sham (placebo) stimulation. Each child will undergo two sets of 15 sessions during which tDCS is applied alongside cognitive training exercises. The goal is to compare the changes in ADHD symptoms between the group receiving actual brain stimulation and the group receiving sham stimulation over a period of 4 weeks. Participants will be assessed using the ADHD Rating Scale-IV to measure symptom changes. Eligibility involves clinical evaluations, including intellectual assessments and symptom rating scales like the ADHD-RS and CGI. Children previously on stimulant medication must have stopped it for at least seven days before participation. Safety considerations include monitoring for neurological or psychiatric conditions and contraindications to tDCS. The study will monitor symptom variation at 4 weeks, with involvement lasting through the treatment period.

Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD)