Effect of iTBS on Children With ADHD

NCT06010966 | Recruiting

• 1 other identifier: IIT20220110C-R2
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD; rTMS

Outcome Measures

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.

  4 weeks

Secondary Outcomes (3)

• fMRI

  4 weeks

• Stroop color-wordtask (SCWT)

  4 weeks

• TMT task

  4 weeks

Study Arms (3)

sham group

SHAM COMPARATOR

receive sham itbs

Device: rTMS

low-dose group

ACTIVE COMPARATOR

receive low dose of itbs

Device: rTMS

high-dose group

ACTIVE COMPARATOR

receive high dose of itbs

Device: rTMS

Interventions

rTMS DEVICE

intermittent theta-burst stimulation (iTBS)

high-dose group; low-dose group; sham group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Shaohua Hu, Dr

  Zhejiang University

  STUDY CHAIR

Central Study Contacts

Shaohua Hu, Dr

CONTACT

0571-87235987; dorhushaohua@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 25, 2023
• Study Start: September 1, 2023
• Primary Completion: July 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)