Dual-target iTBS for Youth With ADHD
Recruiting now · Phase 1/Phase 2 · Has a placebo group
Conditions studied: ADHD
In brief
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.
Key facts
- Study ID
- NCT07084649
- Run by
- Shanghai Mental Health Center
- People needed
- 15
- Starts
- 2025-01-01
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2025-07-24
Who can join
Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ADHD Diagnosis: Meets the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- 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;
- Age and Gender: 10-18 years old; males or females;
- Intellectual Functioning: Full-scale intelligence quotient (IQ) >70 on the China-Wechsler Intelligence Scale for Children (C-WISC) (excluding participants with intellectual disability);
- Symptom Severity: A score of ≥1.6 on either the Inattention or Hyperactivity/Impulsivity subscale of the SNAP-IV Parent Rating Scale;
- Medication Requirements:
- 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.
You may not qualify if…
- Contraindications for TMS therapy include epilepsy, cardiac pacemakers, cochlear implants, and metal implants.
- Contraindications for MRI include metal implants in the body, claustrophobia, and tattoos.
- Significant medical history: history of epilepsy, organic brain disorders, traumatic brain injury (TBI), or severe physical illnesses.
- Behavioral risks: history of violent or suicidal behavior.
- Comorbid neurodevelopmental disorders, such as autism spectrum disorder (ASD), tic disorders, etc.
- Comorbid psychiatric disorders: any other primary psychiatric disorders, except conduct disorder/oppositional defiant disorder, mild anxiety, or depression.
- Substance abuse.
- Currently receiving any non-medical treatments, such as cognitive behavioral therapy (CBT), neurofeedback, etc.
- Female participants must not be pregnant or breastfeeding.
Where it is running
- Shanghai Mental Health Center — Shanghai, None Selected, China (enrolling)
Full record on ClinicalTrials.gov
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