Effect of iTBS on Children With ADHD

ADHD Clinical Trial

Official title:

Effect of Intermittent TBS on Children With ADHD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06010966
• Other study ID #: IIT20220110C-R2
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: July 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Shaohua Hu, Dr
• Phone: 0571-87235987
• Email: dorhushaohua[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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;

Related Conditions & MeSH terms

• ADHD
• rTMS

Intervention

Device:
• rTMS
intermittent theta-burst stimulation (iTBS)

Locations

Country	Name	City	State
China	Department of Psychiatry, First Affiliated Hospital of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD-RS	Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS), range from 0 to 54 points. The high scores means the worse outcome.	4 weeks
Secondary	fMRI	functional magnetic resonance imaging	4 weeks
Secondary	Stroop color-wordtask (SCWT)	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	4 weeks
Secondary	TMT task	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	4 weeks