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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Mental Health Center
  Shanghai, None Selected, China Recruiting

Study contacts

• Study coordinator: Huiru Cui, Ph.D
• Email: cuihuiru@163.com
• Phone: +862134773243

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.