ADHDNCT06010966
Effect of iTBS on Children With ADHD
A study testing rTMS in people with ADHD and rTMS, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Psychiatry, First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Hu ShaoHua, 13957162903, dorhushaohua@zju.edu.cn
About this study
Official title: 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.
- Being tested
- rTMS
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
intermittent theta-burst stimulation (iTBS)
| Study group | Role | What they receive |
|---|---|---|
| sham group | Sham comparator | receive sham itbs Receives: Device: rTMS |
| low-dose group | Active comparator | receive low dose of itbs Receives: Device: rTMS |
| high-dose group | Active comparator | receive high dose of itbs Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD-RS
Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS), range from 0 to 54 points. The high scores means the worse outcome.
Measured: 4 weeks
Secondary outcomes (3)
fMRI
functional magnetic resonance imaging
Measured: 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
Measured: 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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start1 Sep 2023
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu ShaoHua, First Affiliated Hospital of Zhejiang University
- Investigators
- Shaohua Hu, Dr, Study chair, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010966
- Sponsor's protocol ID
- IIT20220110C-R2
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: individual participant data (IPD) is aviliable from Principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intermittent TBS on Children With ADHD
- ClinicalTrials.gov ID
- NCT06010966
- Acronym / sponsor ID
- IIT20220110C-R2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sham group | Sham comparator | Device: rTMSreceive sham itbs |
| low-dose group | Active comparator | Device: rTMSreceive low dose of itbs |
| high-dose group | Active comparator | Device: rTMSreceive high dose of itbs |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSintermittent theta-burst stimulation (iTBS) | Device | high-dose group, low-dose group, sham group |
Primary outcome
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.
3 secondary outcomes
fMRI
Time frame: 4 weeks
Stroop color-wordtask (SCWT)
Time frame: 4 weeks
TMT task
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Individual participant dataSharing planned: No. individual participant data (IPD) is aviliable from Principal investigator
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaohua Hu, Dr study chair
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with ADHD and rTMS, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaohua Hu, Dr (0571-87235987, dorhushaohua@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD-RS (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.