Effect of iTBS on Children With ADHD

NCT ID: NCT06010966

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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ADHD rTMS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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sham group

receive sham itbs

Group Type SHAM_COMPARATOR

rTMS

Intervention Type DEVICE

intermittent theta-burst stimulation (iTBS)

low-dose group

receive low dose of itbs

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type DEVICE

intermittent theta-burst stimulation (iTBS)

high-dose group

receive high dose of itbs

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type DEVICE

intermittent theta-burst stimulation (iTBS)

Interventions

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rTMS

intermittent theta-burst stimulation (iTBS)

Intervention Type DEVICE

Eligibility Criteria

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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;
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Hu ShaoHua

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shaohua Hu, Dr

Role: STUDY_CHAIR

Zhejiang University

Locations

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Department of Psychiatry, First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shaohua Hu, Dr

Role: CONTACT

Phone: 0571-87235987

Email: [email protected]

Facility Contacts

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Hu ShaoHua

Role: primary

Other Identifiers

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IIT20220110C-R2

Identifier Type: -

Identifier Source: org_study_id