Health TrialsbyHealthPanel

Effect of iTBS on Children With ADHD

ConditionsADHDrTMS
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • rTMS

    Device

    intermittent theta-burst stimulation (iTBS)

Treatment groups

54 Participants
are divided into 3 treatment groups
Group A: sham groupSham comparator 1 intervention
Group B: low-dose groupActive comparator 1 intervention
Group C: high-dose groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ADHD-RS

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

Time frame
4 weeks

Secondary outcomes

1

fMRI

functional magnetic resonance imaging

Time frame
4 weeks
2

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

Time frame
4 weeks
3

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

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
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