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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
accelerated intermittent theta burst stimulation
Shanghai Mental Health Center
Shanghai, None Selected, China
RECRUITINGEffectiveness as measured by SNAP-IV Parent Rating Scale (assessing inattention/hyperactivity-impulsivity)
SNAP-IV is used to assess the core symptoms of ADHD (inattention, hyperactivity/impulsivity) and symptoms of oppositional defiant disorder; the total score or subscale mean scores indicate symptom severity, with higher scores reflecting more pronounced symptoms.
Time frame: ADHD symptoms will be measured before the TMS treatment, immediately after completion of the TMS treatment.
Clinical Global Impression-Severity Scale (CGI)
CGI is used to evaluate disease severity and treatment response.
Time frame: GCI will be measured before the TMS treatment, immediately after completion of the TMS treatment.
Safety as measured by number of participants with Adverse Events
Count of Adverse Events Reported during follow up
Time frame: Each afternoon after treatment during the 5 days of treatment
Acceptability as assessed by treatment-related dropout rates
Acceptability is assessed by treatment-related dropout rates, such as dropouts due to TMS side effects or lack of efficacy
Time frame: Each afternoon after treatment during the 5 days of treatment
BRIEF（Behavior Rating Inventory of Executive Function）
To assess behavioral manifestations of executive function in children, and adolescents
Time frame: Will be measured before the TMS treatment, immediately after completion of the TMS treatment.
PedsQL（Pediatric Quality of Life Inventory）
To measure health-related quality of life in children and adolescents, covering physical, emotional, and social functioning.
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Time frame: Will be measured before the TMS treatment, immediately after completion of the TMS treatment.
A cognitive task battery
Trail Making Test (TMT): Part A; WMS III Spatial Span; Brief Visuospatial Memory Test-Revised NAB Mazes; CPT-IP; N-back task; Go/No-Go task; Flanker tasks.
Time frame: Will be measured before the TMS treatment, immediately after completion of the TMS treatment.
Cortical excitability and cortical inhibition function indicators
Resting motor threshold, 1mV motor evoked potential threshold and amplitude, short-interval cortical inhibition and intracortical facilitation
Time frame: Will be measured before the TMS treatment, immediately after completion of the TMS treatment.