ADHDPhase 1/2NCT07084649
Dual-target iTBS for Youth With ADHD
A Phase 1/2 study testing TMS in people with ADHD, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
This study will employ accelerated intermittent theta burst stimulation (aiTBS) targeting two transcranial magnetic stimulation (TMS) sites: the right inferior frontal gyrus and left inferior parietal lobule. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- ADHD
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 30 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ADHD Diagnosis: Meets the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- Inadequate Response to Medication: After a full course of pharmacological treatment, the SNAP-IV Parent Rating Scale (first 18 items, assessing inattention/hyperactivity-impulsivity) score >1, and the Clinical Global Impression-Severity Scale (CGI-S) score >2;
- Age and Gender: 10-18 years old; males or females;
- Intellectual Functioning: Full-scale intelligence quotient (IQ) >70 on the China-Wechsler Intelligence Scale for Children (C-WISC) (excluding participants with intellectual disability);
- Symptom Severity: A score of ≥1.6 on either the Inattention or Hyperactivity/Impulsivity subscale of the SNAP-IV Parent Rating Scale;
- Medication Requirements:
- 1) Medication-naïve or currently off medication; 2) If currently on medication, must be on a stable medication regimen for at least 4 weeks prior to the baseline visit and throughout the study duration; 3) Prohibited medications: Psychostimulants; 7. Right-handed.
Who cannot join
- Contraindications for TMS therapy include epilepsy, cardiac pacemakers, cochlear implants, and metal implants.
- Contraindications for MRI include metal implants in the body, claustrophobia, and tattoos.
- Significant medical history: history of epilepsy, organic brain disorders, traumatic brain injury (TBI), or severe physical illnesses.
- Behavioral risks: history of violent or suicidal behavior.
- Comorbid neurodevelopmental disorders, such as autism spectrum disorder (ASD), tic disorders, etc.
- Comorbid psychiatric disorders: any other primary psychiatric disorders, except conduct disorder/oppositional defiant disorder, mild anxiety, or depression.
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- Substance abuse.
- Currently receiving any non-medical treatments, such as cognitive behavioral therapy (CBT), neurofeedback, etc.
- Female participants must not be pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Mental Health Center
Shanghai, None Selected, 200030
Huiru Cui, 18918049951, cuihuiru@163.com
About this study
Official title: The Efficacy of Dual-target iTBS in Youth With Attention-Deficit/Hyperactivity Disorder (ADHD)
This study will employ accelerated intermittent theta burst stimulation (aiTBS) targeting two transcranial magnetic stimulation (TMS) sites: the right inferior frontal gyrus and left inferior parietal lobule.
Read the detailed description
ADHD is the most common neurodevelopmental disorder in childhood. First-line clinical treatments primarily rely on psychostimulants, yet approximately 30% of adolescents with ADHD show inadequate response to current therapies. There is an urgent need to develop novel, practical, and sensitive intervention strategies.
Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive technique that modulates neural activity via magnetic fields applied to brain regions beneath the skull, can induce long-lasting positive changes in neuroplasticity. This provides an alternative therapeutic approach for ADHD. In clinical research, rTMS has demonstrated potential value in treating children with ADHD. Notably, current studies have limitations: lack of control groups makes it difficult to exclude placebo effects, and the commonly used DLPFC target shows suboptimal efficacy in improving both clinical symptoms and cognitive functions, indicating room for improvement.
This study will be conducted in two phases:
- Phase 1 is an open-label, single-arm study to explore the preliminary efficacy, safety, and acceptability of aiTBS for youth with ADHD.
- Phase 2 is a randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS and establish causal conclusions through a controlled design.
The decision to proceed depends on Phase 1 results:
- If Phase 1 demonstrates positive outcomes in clinical symptoms, cognitive functioning, safety, and acceptability, Phase 2 will be implemented.
- If Phase 1 fails to show positive results, Phase 2 will be discontinued.
The study will utilize MRI-guided neuronavigation to precisely locate the target brain regions (the right inferior frontal gyrus and the left inferior parietal lobule) for each participant. An aiTBS protocol will be employed. Based on a 90% resting motor threshold (adjusted for cortical depth), each participant will receive 10 iTBS sessions (1,800 pulses per session, with 60-minute inter-session intervals), administered twice daily over five consecutive days.
- Conditions
- ADHD
- Being tested
- TMS
- 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.
TMSDevice
accelerated intermittent theta burst stimulation
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Open-label dual-target aiTBS | Experimental | Phase 1: Open label, single arm study to determine the preliminary efficacy, safety, and acceptability of aiTBS for youth with ADHD. Receives: Device: TMS |
| Phase 2: RCT design active aiTBS | Active comparator | Phase 1: A randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS for youth with ADHD. Receives: Device: TMS |
| Phase 2: RCT design sham aiTBS | Sham comparator | Phase 2: A randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS for youth with ADHD. Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness as measured by SNAP-IV Parent Rating Scale (assessing inattention/hyperactivity-impulsivity)
SNAP-IV is used to assess the core symptoms of ADHD (inattention, hyperactivity/impulsivity) and symptoms of oppositional defiant disorder; the total score or subscale mean scores indicate symptom severity, with higher scores reflecting more pronounced symptoms.
Measured: ADHD symptoms will be measured before the TMS treatment, immediately after completion of the TMS treatment.
Clinical Global Impression-Severity Scale (CGI)
CGI is used to evaluate disease severity and treatment response.
Measured: GCI will be measured before the TMS treatment, immediately after completion of the TMS treatment.
Secondary outcomes (6)
Safety as measured by number of participants with Adverse Events
Count of Adverse Events Reported during follow up
Measured: Each afternoon after treatment during the 5 days of treatment
Acceptability as assessed by treatment-related dropout rates
Acceptability is assessed by treatment-related dropout rates, such as dropouts due to TMS side effects or lack of efficacy
Measured: Each afternoon after treatment during the 5 days of treatment
BRIEF（Behavior Rating Inventory of Executive Function）
To assess behavioral manifestations of executive function in children, and adolescents
Measured: Will be measured before the TMS treatment, immediately after completion of the TMS treatment.
PedsQL（Pediatric Quality of Life Inventory）
To measure health-related quality of life in children and adolescents, covering physical, emotional, and social functioning.
Measured: Will be measured before the TMS treatment, immediately after completion of the TMS treatment.
A cognitive task battery
Trail Making Test (TMT): Part A; WMS III Spatial Span; Brief Visuospatial Memory Test-Revised NAB Mazes; CPT-IP; N-back task; Go/No-Go task; Flanker tasks.
Measured: Will be measured before the TMS treatment, immediately after completion of the TMS treatment.
Cortical excitability and cortical inhibition function indicators
Resting motor threshold, 1mV motor evoked potential threshold and amplitude, short-interval cortical inhibition and intracortical facilitation
Measured: Will be measured before the TMS treatment, immediately after completion of the TMS treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Jan 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion30 Dec 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 Shanghai Mental Health CenterThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Phase 1 is an open-label, single-arm study to explore the preliminary efficacy, safety, and acceptability of aiTBS for youth with ADHD. • Phase 2 is a randomized, double-masked, controlled trial that will rigorously validate the results of Phase 1. The decision to proceed depends on Phase 1 results: * If Phase 1 demonstrates positive outcomes in clinical symptoms, cognitive functioning, safety, and acceptability, Phase 2 will be implemented. * If Phase 1 fails to show positive results, Phase 2 will be discontinued.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084649
- Sponsor's protocol ID
- IRB, SMHC, 2025-01
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This requires approval from our institution's ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Dual-target iTBS in Youth With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT07084649
- Acronym / sponsor ID
- IRB, SMHC, 2025-01
- Conditions
- ADHD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Jul 2025 (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.
This study will employ accelerated intermittent theta burst stimulation (aiTBS) targeting two transcranial magnetic stimulation (TMS) sites: the right inferior frontal gyrus and left inferior parietal lobule.
Detailed description
ADHD is the most common neurodevelopmental disorder in childhood. First-line clinical treatments primarily rely on psychostimulants, yet approximately 30% of adolescents with ADHD show inadequate response to current therapies. There is an urgent need to develop novel, practical, and sensitive intervention strategies.
Repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive technique that modulates neural activity via magnetic fields applied to brain regions beneath the skull, can induce long-lasting positive changes in neuroplasticity. This provides an alternative therapeutic approach for ADHD. In clinical research, rTMS has demonstrated potential value in treating children with ADHD. Notably, current studies have limitations: lack of control groups makes it difficult to exclude placebo effects, and the commonly used DLPFC target shows suboptimal efficacy in improving both clinical symptoms and cognitive functions, indicating room for improvement.
This study will be conducted in two phases:
- Phase 1 is an open-label, single-arm study to explore the preliminary efficacy, safety, and acceptability of aiTBS for youth with ADHD.
- Phase 2 is a randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS and establish causal conclusions through a controlled design.
The decision to proceed depends on Phase 1 results:
- If Phase 1 demonstrates positive outcomes in clinical symptoms, cognitive functioning, safety, and acceptability, Phase 2 will be implemented.
- If Phase 1 fails to show positive results, Phase 2 will be discontinued.
The study will utilize MRI-guided neuronavigation to precisely locate the target brain regions (the right inferior frontal gyrus and the left inferior parietal lobule) for each participant. An aiTBS protocol will be employed. Based on a 90% resting motor threshold (adjusted for cortical depth), each participant will receive 10 iTBS sessions (1,800 pulses per session, with 60-minute inter-session intervals), administered twice daily over five consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase 1 is an open-label, single-arm study to explore the preliminary efficacy, safety, and acceptability of aiTBS for youth with ADHD. • Phase 2 is a randomized, double-masked, controlled trial that will rigorously validate the results of Phase 1. The decision to proceed depends on Phase 1 results: * If Phase 1 demonstrates positive outcomes in clinical symptoms, cognitive functioning, safety, and acceptability, Phase 2 will be implemented. * If Phase 1 fails to show positive results, Phase 2 will be discontinued.
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Open-label dual-target aiTBS | Experimental | Device: TMSPhase 1: Open label, single arm study to determine the preliminary efficacy, safety, and acceptability of aiTBS for youth with ADHD. |
| Phase 2: RCT design active aiTBS | Active comparator | Device: TMSPhase 1: A randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS for youth with ADHD. |
| Phase 2: RCT design sham aiTBS | Sham comparator | Device: TMSPhase 2: A randomized, double-masked, controlled trial that will rigorously validate the efficacy and safety of dual-target aiTBS for youth with ADHD. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- ADHD Diagnosis: Meets the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5);
- Inadequate Response to Medication: After a full course of pharmacological treatment, the SNAP-IV Parent Rating Scale (first 18 items, assessing inattention/hyperactivity-impulsivity) score >1, and the Clinical Global Impression-Severity Scale (CGI-S) score >2;
- Age and Gender: 10-18 years old; males or females;
- Intellectual Functioning: Full-scale intelligence quotient (IQ) >70 on the China-Wechsler Intelligence Scale for Children (C-WISC) (excluding participants with intellectual disability);
- Symptom Severity: A score of ≥1.6 on either the Inattention or Hyperactivity/Impulsivity subscale of the SNAP-IV Parent Rating Scale;
Key exclusion criteria (9 listed)
- Contraindications for TMS therapy include epilepsy, cardiac pacemakers, cochlear implants, and metal implants.
- Contraindications for MRI include metal implants in the body, claustrophobia, and tattoos.
- Significant medical history: history of epilepsy, organic brain disorders, traumatic brain injury (TBI), or severe physical illnesses.
- Behavioral risks: history of violent or suicidal behavior.
- Comorbid neurodevelopmental disorders, such as autism spectrum disorder (ASD), tic disorders, etc.
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 |
|---|---|---|
| TMSaccelerated intermittent theta burst stimulation | Device | Phase 1: Open-label dual-target aiTBS, Phase 2: RCT design active aiTBS, Phase 2: RCT design sham aiTBS |
Primary outcome
Effectiveness as measured by SNAP-IV Parent Rating Scale (assessing inattention/hyperactivity-impulsivity)
Time frame: ADHD symptoms will be measured before the TMS treatment, immediately after completion of the TMS treatment.
SNAP-IV is used to assess the core symptoms of ADHD (inattention, hyperactivity/impulsivity) and symptoms of oppositional defiant disorder; the total score or subscale mean scores indicate symptom severity, with higher scores reflecting more pronounced symptoms.
Clinical Global Impression-Severity Scale (CGI)
Time frame: GCI will be measured before the TMS treatment, immediately after completion of the TMS treatment.
CGI is used to evaluate disease severity and treatment response.
6 secondary outcomes
Safety as measured by number of participants with Adverse Events
Time frame: Each afternoon after treatment during the 5 days of treatment
Acceptability as assessed by treatment-related dropout rates
Time frame: Each afternoon after treatment during the 5 days of treatment
BRIEF（Behavior Rating Inventory of Executive Function）
Time frame: Will be measured before the TMS treatment, immediately after completion of the TMS treatment.
PedsQL（Pediatric Quality of Life Inventory）
Time frame: Will be measured before the TMS treatment, immediately after completion of the TMS treatment.
A cognitive task battery
Time frame: Will be measured before the TMS treatment, immediately after completion of the TMS treatment.
Cortical excitability and cortical inhibition function indicators
Time frame: Will be measured before the TMS treatment, immediately after completion of the TMS treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: No. This requires approval from our institution's ethics committee.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TMS in people with ADHD, run by Shanghai Mental Health Center 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 9 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: looking for participants now, as of the sponsor's last update on 24 Jul 2025. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huiru Cui, Ph.D (+862134773243, cuihuiru@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness as measured by SNAP-IV Parent Rating Scale (assessing inattention/hyperactivity-impulsivity) (time frame: ADHD symptoms will be measured before the TMS treatment, immediately after completion of the TMS treatment.). The study lists 2 primary outcomes in all. 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 24 Jul 2025.