Effect of iTBS on Children With ADHD

Not Applicable

Recruiting

• Conditions: ADHD; rTMS
• Interventions: Device: rTMS

• Registration Number: NCT06010966
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-08-24
• Study First Posted: 2023-08-25
• Study Start: 2023-09-01
• Last Update Submitted: 2023-12-06
• Last Update Posted: 2023-12-13
• Primary Completion: 2025-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low-dose group	rTMS	receive low dose of itbs
high-dose group	rTMS	receive high dose of itbs
sham group	rTMS	receive sham itbs

Primary Outcome Measures

Name	Time	Method
ADHD-RS	4 weeks	Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS), range from 0 to 54 points. The high scores means the worse outcome.

Secondary Outcome Measures

Name	Time	Method
fMRI	4 weeks	functional magnetic resonance imaging
Stroop color-wordtask (SCWT)	4 weeks	In the SCWT, the stimuli were two Chinese color words (green and red) presented in matching or contrasting font colors. The participants were asked to respond to the color of the font as quickly and as accurately as possible when a word was presented
TMT task	4 weeks	trailmaking test,TMT；It is divided into two parts: A and B. Part A requires the participants to connect 25 numbers on the paper in order (Figure 2). Part B includes 1-13 numbers and A-L12 letters, requiring participants to alternately connect these numbers and letters in orde

Trial Locations

Locations (1)

Department of Psychiatry, First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China