NCT07084649

Dual-target iTBS for Youth With ADHD

The Efficacy of Dual-target iTBS in Youth With Attention-Deficit/Hyperactivity Disorder (ADHD)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This study will employ accelerated intermittent theta burst stimulation (aiTBS) targeting two transcranial magnetic stimulation (TMS) sites: the right inferior frontal gyrus and left inferior parietal lobule.

Detailed description

ADHD is the most common neurodevelopmental disorder in childhood. First-line clinical treatments primarily rely on psychostimulants, yet approximately 30% of adolescents with ADHD show inadequate response to current therapies. There is an urgent need to develop novel, practical, and sensitive intervention strategies. Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive technique that modulates neural activity via magnetic fields applied to brain regions beneath the skull, can induce long-lasting positive changes in neuroplasticity. This provides an alternative therapeutic approach for ADHD. In clinical research, rTMS has demonstrated potential value in treating children with ADHD. Notably, current studies have limitations: lack of control groups makes it difficult to exclude placebo effects, and the commonly used DLPFC target shows suboptimal efficacy in improving both clinical symptoms and cognitive functions, indicating room for improvement. This study will be conducted in two phases: * Phase 1 is an open-label, single-arm study to explore the preliminary efficacy, safety, and acceptability of aiTBS for youth with ADHD. * Phase 2 is a randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS and establish causal conclusions through a controlled design. The decision to proceed depends on Phase 1 results: * If Phase 1 demonstrates positive outcomes in clinical symptoms, cognitive functioning, safety, and acceptability, Phase 2 will be implemented. * If Phase 1 fails to show positive results, Phase 2 will be discontinued. The study will utilize MRI-guided neuronavigation to precisely locate the target brain regions (the right inferior frontal gyrus and the left inferior parietal lobule) for each participant. An aiTBS protocol will be employed. Based on a 90% resting motor threshold (adjusted for cortical depth), each participant will receive 10 iTBS sessions (1,800 pulses per session, with 60-minute inter-session intervals), administered twice daily over five consecutive days.

Conditions

• ADHD

Interventions

Type	Name	Description
DEVICE	TMS	accelerated intermittent theta burst stimulation

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-09-01
• Completion: 2026-12-30
• First posted: 2025-07-24
• Last updated: 2025-07-24

Locations

1 site across 1 country: China