Effect of iTBS on Children With ADHD

Last updated: December 6, 2023
Sponsor: First Affiliated Hospital of Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Treatment

rTMS

Clinical Study ID

NCT06010966
IIT20220110C-R2
  • Ages 6-12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Concomitant mental disorders such as anxiety and depression;
  • Widespread developmental disorders and other neurological developmental relateddisorders;
  • 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 moodstabilizers 3 months prior to enrollment or during rTMS treatment; In addition to theminimum effective therapeutic dose of Tomoxetine (1.2-1.4 mg • kg/day), there has beensystematic use of first-line ADHD drugs in clinical practice Webster's intelligence<70
  • Implantation of metal and electronic components in the body (excluding the oralcavity), such as pacemakers;

Study Design

Total Participants: 54
Treatment Group(s): 1
Primary Treatment: rTMS
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
July 31, 2026

Connect with a study center

  • Department of Psychiatry, First Affiliated Hospital of Zhejiang University

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

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