A Phase 3 trial investigating transcranial direct current stimulation (tDCS) for Attention Deficit/Hyperactivity Disorder (ADHD) reached primary completion on 2025-08-31, enrolling 150 participants.

Background

Attention-Deficit/Hyperactivity Disorder (ADHD) is the most commonly diagnosed neurodevelopmental disorder in childhood. It is characterized by persistent patterns of inattention, impulsivity, and hyperactivity, which can severely impact academic achievement, social interactions, and daily functioning. While pharmacological treatments, particularly stimulant medications, are effective for a majority of children with ADHD, a significant portion—approximately 30%—do not respond to these treatments or experience intolerable side effects. Furthermore, some parents may prefer or seek non-pharmacological alternatives for their children. Transcranial Direct Current Stimulation (tDCS) is being explored as a non-invasive brain stimulation technique, offering a potential novel approach for managing ADHD symptoms, especially for those who cannot use or tolerate existing medications.

Trial design

This Phase 3 study, identified as NCT04704687, enrolled 150 participants to investigate Attention Deficit Hyperactivity Disorder. The trial's primary objective is to examine the clinical efficacy and long-term effects of Transcranial Direct Current Stimulation (tDCS) in children diagnosed with ADHD. The study is designed to assess the potential benefits of this non-invasive intervention for managing ADHD symptoms.

What this means

The primary completion of this Phase 3 trial signifies that data collection for its main objectives has concluded. This represents an important milestone in the ongoing evaluation of Transcranial Direct Current Stimulation (tDCS) as a potential non-pharmacological intervention for children with ADHD. The findings from this study are anticipated to offer valuable insights for clinicians, patients, and families, particularly those who do not respond to or tolerate conventional stimulant medications, or for those actively seeking alternative treatment options. The full results of the trial are now awaited to determine the efficacy and long-term impact of tDCS in this population.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a publicly accessible database of clinical studies. The update for study NCT04704687, titled "Clinical Efficacy and Long Term Effects of Transcranial Direct Current Stimulation (tDCS) in Children With Attention Deficit/Hyperactivity Disorder (ADHD)", was posted on 2025-08-31 on clinicaltrials.gov.