Effect of iTBS on Children With ADHD

Zhejiang University

Status: Enrolling

Conditions: rTMS; ADHD

Treatments: Device: rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT06010966

IIT20220110C-R2

Details and patient eligibility

About

Attention Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder characterized by persistent symptoms of attention deficit and/or hyperactivity/impulsivity . Currently, the first line drugs for treating ADHD are central stimulants such as Tomoxetine and Guanfaxine. However, there is a risk of drug abuse and misuse, which often affects sleep and appetite, only 50% of patients can fully tolerate. This project uses the iTBS stimulation on weekends, children with ADHD finish scale evaluation, magnetic resonance imaging analysis, and cognitive function before and after stimulation, This study explores its therapeutic effect on attention deficit in children and adolescents with ADHD.

Enrollment: 54 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 3 patient groups

sham group

Sham Comparator group

Description:

receive sham itbs

Treatment:

Device: rTMS

low-dose group

Active Comparator group

Description:

receive low dose of itbs

Treatment:

Device: rTMS

high-dose group

Active Comparator group

Description:

receive high dose of itbs

Treatment:

Device: rTMS