Dual-target accelerated theta burst brain stimulation for youth with ADHD

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

This trial will test whether a fast, dual-target form of noninvasive brain stimulation (accelerated intermittent theta burst stimulation) helps 10- to 18-year-olds with ADHD who haven't responded well to medication.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 10 Years to 18 Years
• Sex: All
• Sponsor: Shanghai Mental Health Center (Academic / other)
• Locations: 1 site (Shanghai, None Selected)
• Trial ID: NCT07084649 on ClinicalTrials.gov

What this trial studies

The study applies accelerated intermittent theta burst stimulation (aiTBS) to two brain sites—the right inferior frontal gyrus and the left inferior parietal lobule—using a noninvasive magnetic stimulation device. Phase 1 is an open-label, single-arm pilot to examine preliminary safety, acceptability, and signals of benefit on symptoms and cognitive function. If Phase 1 shows positive clinical and cognitive changes without safety concerns, Phase 2 will be a randomized, double-masked, controlled trial comparing dual-target aiTBS to a control condition to establish efficacy and safety. Outcome measures include changes in ADHD symptom ratings and cognitive performance over the treatment course.

Who should consider this trial

Good fit: Ideal candidates are 10–18-year-olds with DSM-5 ADHD who have had an inadequate response to a full course of medication and have an IQ above 70.

Not a fit: Patients who are doing well on current medication, have intellectual disability (IQ ≤70), or cannot tolerate TMS are unlikely to receive benefit from this intervention.

Why it matters

Potential benefit: If successful, this could provide a non-drug treatment option that reduces ADHD symptoms and improves attention and cognitive function in adolescents.

How similar studies have performed: Some rTMS studies in children with ADHD have reported promising signals, but many lacked control groups and the specific dual-target accelerated iTBS approach is relatively novel and unproven.

Eligibility criteria

Inclusion Criteria:

1. ADHD Diagnosis: Meets the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
2. Inadequate Response to Medication: After a full course of pharmacological treatment, the SNAP-IV Parent Rating Scale (first 18 items, assessing inattention/hyperactivity-impulsivity) score \>1, and the Clinical Global Impression-Severity Scale (CGI-S) score \>2;
3. Age and Gender: 10-18 years old; males or females;
4. Intellectual Functioning: Full-scale intelligence quotient (IQ) \>70 on the China-Wechsler Intelligence Scale for Children (C-WISC) (excluding participants with intellectual disability);
5. Symptom Severity: A score of ≥1.6 on either the Inattention or Hyperactivity/Impulsivity subscale of the SNAP-IV Parent Rating Scale;
6. Medication Requirements:

1\) Medication-naïve or currently off medication; 2) If currently on medication, must be on a stable medication regimen for at least 4 weeks prior to the baseline visit and throughout the study duration; 3) Prohibited medications: Psychostimulants; 7. Right-handed.

Exclusion Criteria:

1. Contraindications for TMS therapy include epilepsy, cardiac pacemakers, cochlear implants, and metal implants.
2. Contraindications for MRI include metal implants in the body, claustrophobia, and tattoos.
3. Significant medical history: history of epilepsy, organic brain disorders, traumatic brain injury (TBI), or severe physical illnesses.
4. Behavioral risks: history of violent or suicidal behavior.
5. Comorbid neurodevelopmental disorders, such as autism spectrum disorder (ASD), tic disorders, etc.
6. Comorbid psychiatric disorders: any other primary psychiatric disorders, except conduct disorder/oppositional defiant disorder, mild anxiety, or depression.
7. Substance abuse.
8. Currently receiving any non-medical treatments, such as cognitive behavioral therapy (CBT), neurofeedback, etc.
9. Female participants must not be pregnant or breastfeeding.

Where this trial is running

Shanghai, None Selected

• Shanghai Mental Health Center — Shanghai, None Selected, China (Recruiting)

Study contacts

• Study coordinator: Huiru Cui, Ph.D

Conditions ADHD