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Clinical Trials in China / NCT07084649
Recruiting Phase 1/2

Dual-target iTBS for Youth With ADHD

NCT07084649 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Mental Health Center
Phase
Phase 1/2
Started
2025-01-01
Last updated
2025-07-24

Condition(s) studied

ADHD

Investigational drug(s) / intervention(s)

TMS

TMS: accelerated intermittent theta burst stimulation

Study 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.

Eligibility

Sex
ALL
Min age
10 Years
Max age
18 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Shanghai Mental Health Center Shanghai None Selected Recruiting

More Shanghai Mental Health Center trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07084649 on ClinicalTrials.gov ↗ ← All trials in China