Effect of iTBS on Children With ADHD

Effect of Intermittent TBS on Children With ADHD

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.

Study Overview

• Status: Recruiting
• Conditions: ADHD; rTMS
• Intervention / Treatment: Device: rTMS

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shaohua Hu, Dr; Phone Number: 0571-87235987; Email: dorhushaohua@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Department of Psychiatry, First Affiliated Hospital of Zhejiang University
      • Contact: Hu ShaoHua; Phone Number: 13957162903; Email: dorhushaohua@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: sham group; receive sham itbs	Device: rTMS; intermittent theta-burst stimulation (iTBS)
Active Comparator: low-dose group; receive low dose of itbs	Device: rTMS; intermittent theta-burst stimulation (iTBS)
Active Comparator: high-dose group; receive high dose of itbs	Device: rTMS; intermittent theta-burst stimulation (iTBS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
fMRI	functional magnetic resonance imaging	4 weeks
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	4 weeks
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	4 weeks

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Study Chair: Shaohua Hu, Dr, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IIT20220110C-R2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: individual participant data (IPD) is aviliable from Principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No