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Effect of iTBS on Children With ADHD

Effect of Intermittent TBS on Children With ADHD

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06010966
Enrollment
54
Registered
2023-08-25
Start date
2023-09-01
Completion date
2026-07-31
Last updated
2023-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ADHD, rTMS

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.

Interventions

DEVICErTMS

intermittent theta-burst stimulation (iTBS)

Sponsors

First Affiliated Hospital of Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
ADHD-RS4 weeksAttention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS), range from 0 to 54 points. The high scores means the worse outcome.

Secondary

MeasureTime frameDescription
fMRI4 weeksfunctional magnetic resonance imaging
Stroop color-wordtask (SCWT)4 weeksIn 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 task4 weekstrailmaking 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

Countries

China

Contacts

Primary ContactShaohua Hu, Dr
dorhushaohua@zju.edu.cn0571-87235987

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026