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Clinical Trials/NCT06010966
NCT06010966
Recruiting
Not Applicable

Effect of Intermittent TBS on Children With ADHD

First Affiliated Hospital of Zhejiang University1 site in 1 country54 target enrollmentSeptember 1, 2023
ConditionsADHDrTMS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ADHD
Sponsor
First Affiliated Hospital of Zhejiang University
Enrollment
54
Locations
1
Primary Endpoint
ADHD-RS
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2023
End Date
July 31, 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
First Affiliated Hospital of Zhejiang University
Responsible Party
Principal Investigator
Principal Investigator

Hu ShaoHua

professor

First Affiliated Hospital of Zhejiang University

Eligibility Criteria

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;

Outcomes

Primary Outcomes

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

  • fMRI(4 weeks)
  • Stroop color-wordtask (SCWT)(4 weeks)
  • TMT task(4 weeks)

Study Sites (1)

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