Using iTBS to treat ADHD in children
Effect of Intermittent TBS on Children With ADHD
NA · First Affiliated Hospital of Zhejiang University · NCT06010966
This study is testing if a new brain stimulation treatment can help children with ADHD improve their attention and focus without the side effects of traditional medications.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06010966 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of intermittent theta burst stimulation (iTBS) on children diagnosed with Attention Deficit/Hyperactivity Disorder (ADHD). It aims to evaluate the therapeutic impact of rTMS on attention deficits by conducting assessments before and after treatment, including cognitive function tests and MRI analysis. The intervention is administered on weekends, targeting children aged 6 to 12 years who meet specific inclusion criteria. The study seeks to provide an alternative to traditional stimulant medications, which can have significant side effects.
Who should consider this trial
Good fit: Ideal candidates are right-handed children aged 6-12 years with a clinical diagnosis of ADHD who have been experiencing symptoms for more than six months.
Not a fit: Patients with concurrent mental disorders, significant organ diseases, or those who cannot tolerate rTMS treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a non-pharmacological treatment option for children with ADHD, reducing reliance on stimulant medications.
How similar studies have performed: While the use of rTMS in treating ADHD is still emerging, preliminary studies have shown promise, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of ADHD in accordance with DSM-V; * Age 6-12 years old, regardless of gender * Right-handed * Han nationality or born in the Han nationality Ghetto * The course of the disease is greater than 6 months * Webster children's intelligence ≥ 70 * The patient's guardian agrees and signs an informed consent form. Exclusion Criteria: * Concomitant mental disorders such as anxiety and depression; * Widespread developmental disorders and other neurological developmental related disorders; * Complication with other important organ diseases such as heart and lungs; * Suffering from diseases such as epilepsy and tic disorder; * Individuals who cannot tolerate rTMS treatment or cannot cooperate with treatment. * Patients taking psychoactive drugs, antipsychotics, antidepressants, or mood stabilizers 3 months prior to enrollment or during rTMS treatment; In addition to the minimum effective therapeutic dose of Tomoxetine (1.2-1.4 mg • kg/day), there has been systematic use of first-line ADHD drugs in clinical practice Webster's intelligence\<70 * Implantation of metal and electronic components in the body (excluding the oral cavity), such as pacemakers;
Where this trial is running
Hangzhou, Zhejiang
- Department of Psychiatry, First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Shaohua Hu, Dr
- Email: dorhushaohua@zju.edu.cn
- Phone: 0571-87235987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.