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NCT Number: NCT06010966

Effect of iTBS on Children With ADHD

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders Rtms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Hu ShaoHua

CONTACT

[email protected]

13957162903

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

rTMS

Device

intermittent theta-burst stimulation (iTBS)

Primary outcomes

  1. ADHD-RS

    Time frame: 4 weeks

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

Secondary outcomes

  1. fMRI

    Time frame: 4 weeks

    functional magnetic resonance imaging

  2. Stroop color-wordtask (SCWT)

    Time frame: 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

  3. TMT task

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Shaohua Hu, Dr

CONTACT

[email protected]

0571-87235987

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Zhejiang University

Other

Registry information

Official study title

Effect of Intermittent TBS on Children With ADHD

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 25, 2023
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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