NCT07084649 Dual-target iTBS for Youth With ADHD
| NCT ID | NCT07084649 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Shanghai Mental Health Center |
| Condition | ADHD |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2025-01-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07084649 clinical trial?
This trial is open to participants of all sexes, aged 10 Years or older, up to 18 Years, studying ADHD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07084649 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07084649 currently recruiting?
Yes, NCT07084649 is actively recruiting participants. Contact the research team at cuihuiru@163.com for enrollment information.
Where is the NCT07084649 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07084649 clinical trial?
NCT07084649 is sponsored by Shanghai Mental Health Center. The trial plans to enroll 15 participants.