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ADHD - Attention Deficit Disorder With HyperactivityNCT07182344

Brain Stimulation and Attention Control in Children With ADHD

A study testing Intermittent Theta Burst Stimulation to Right DLPFC in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by Neurolab Plus at 2 sites in Kazakhstan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if brain stimulation can help children ages 6 to 12 with attention-deficit/hyperactivity disorder (ADHD) improve their attention and self-control. Read more about this study

Who is it for?
Ages 6 to 12 years
What is being tested?
Intermittent Theta Burst Stimulation to Right DLPFC
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
2 sitesKazakhstan
Study dates
4 Sep 2025to Jun 2026
Phase
Interventional
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 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Children aged 6-12 years at the time of enrollment.
  • Clinical diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD), any presentation type, confirmed using the Vanderbilt ADHD Diagnostic Parent Rating Scale and clinical interview.
  • Intelligence quotient (IQ) ≥ 70 as measured by the General Ability Index (GAI) from the Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V).
  • Ability to understand and follow instructions for the Attention Network Test (ANT) and stimulation procedure.
  • Stable medication regimen for ADHD (if any) for at least 4 weeks before the start of the study.
  • Written informed consent from a parent or legal guardian, and assent from the child when appropriate.

Who cannot join

  • History of epilepsy, seizures, or abnormal EEG suggestive of seizure risk.
  • Presence of metal implants, devices, or foreign bodies in or near the head (except dental fillings) that are contraindicated for TMS or MRI.
  • Serious neurological disorders other than ADHD (e.g., cerebral palsy, brain injury, neurodegenerative disease).
  • Severe psychiatric disorders requiring hospitalization or urgent intervention.
  • Current or past history of significant head trauma with loss of consciousness > 5 minutes.
  • Uncorrected hearing or vision problems that could interfere with task performance.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kazakhstan2 sites

  • Neurolab Plus

    Almaty, 050000

  • Non-profit joint-stock company "Al-Farabi Kazakh National University"

    Almaty, 050040

Other trials in Kazakhstan

About this study

Official title: Effects of iTBS on Cognitive Control in Children With ADHD: A Randomized, Sham-Controlled Study Integrating EEG During ANT, fNIRS, MRI, and Genetic Markers

The goal of this clinical trial is to learn if brain stimulation can help children ages 6 to 12 with attention-deficit/hyperactivity disorder (ADHD) improve their attention and self-control. The main questions it aims to answer are:

Does intermittent theta burst stimulation (iTBS) improve performance on a task that tests attention and reaction times? Can brain activity and genetics help predict who benefits most from this treatment?

Read more

Researchers will compare randomly assigned active iTBS to sham (inactive) stimulation groups to see if the treatment helps.

Participants will:

Receive 10 sessions of either active or sham iTBS over 2 weeks Complete a computer task measuring attention before and after stimulation Wear a brain cap during the task to record EEG signals, also take part in resting-state brain scans, namely magnetic resonance imaging (MRI) and functional near-infrared spectroscopy (fNIRS), and provide a saliva sample for genetic testing

Read the detailed description

This study explores whether noninvasive brain stimulation can improve attention control in children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD), and how biological factors such as brain activity, brain structure, and genetics may predict individual differences in response. The primary focus is on executive attention-the ability to focus on relevant information, ignore distractions, and resolve conflicts between competing signals. These skills are often impaired in children with ADHD and closely linked to underlying differences in brain function.

To address this, the study uses intermittent theta burst stimulation (iTBS), a specialized form of transcranial magnetic stimulation (TMS). This method delivers rapid bursts of magnetic energy in intervals that are designed to increase the excitability of the targeted brain region. The stimulation is applied to the right dorsolateral prefrontal cortex (DLPFC), a key area involved in attention regulation, response inhibition, and cognitive control-functions that are often altered in ADHD.

A total of 40 children between the ages of 6 and 12 will participate. All must have a confirmed diagnosis of ADHD, verified through structured clinical evaluation. To ensure task comprehension and protocol tolerance, all participants must meet a minimum cognitive ability threshold based on a brief IQ screening.

Participants are randomly assigned to receive either active iTBS or sham stimulation. In the sham condition, the procedures and equipment appear identical, but the stimulation coil is positioned in a way that does not affect brain activity. This ensures that results can be attributed to the stimulation itself rather than expectations or placebo effects. Both participants and researchers conducting assessments are unaware of group assignments to maintain blinding.

Each participant undergoes ten sessions of either active or sham iTBS, typically spaced across two weeks. The stimulation protocol is brief-each session lasting only a few minutes-and individualized according to motor threshold testing, which ensures the intensity is appropriate and safe for each child. All procedures are delivered under professional supervision in a child-friendly environment with appropriate hearing protection.

To assess attentional performance, children complete the Attention Network Test (ANT) before and after the stimulation phase. This computerized task measures three key domains of attention: alerting, orienting, and executive control. During the task, children respond to the direction of arrows on the screen, which may be surrounded by distracting cues. This allows researchers to calculate specific reaction-time profiles associated with attention and conflict resolution.

While the ANT is being performed, the study also records electroencephalographic (EEG) data to capture the brain's electrical responses to each trial. EEG is a noninvasive method that tracks fast neural signals in real time using a cap placed on the child's head. It allows for detailed analysis of how the brain prepares for, reacts to, and regulates attentional demands-especially in the milliseconds following stimulus presentation.

In addition, resting-state fNIRS recordings are collected before and after the intervention. fNIRS is a child-friendly brain imaging method that uses near-infrared light to measure blood oxygen levels in the cortex. When the child is at rest, this technique provides insight into the baseline functional state of the DLPFC, allowing researchers to detect changes in regional activation associated with the stimulation.

To explore whether structural brain features may predict stimulation outcomes, each participant also undergoes a one-time MRI scan. This provides high-resolution images of brain anatomy and can reveal differences in cortical thickness, brain volume, or regional structure that may relate to ADHD symptoms or treatment response.

Finally, the study collects genetic material from saliva samples to investigate specific single-nucleotide polymorphisms in genes linked to dopamine signaling, synaptic function, or neurodevelopment. These include candidate genes such as DRD4, DAT1, COMT, and SLC6A3, which have been associated with attentional control and ADHD phenotypes. Genetic data will be used to explore biological moderators of iTBS efficacy.

This multimodal approach-combining behavioral, electrophysiological, neuroimaging, and genetic methods-aims to move beyond the question of whether iTBS is effective for ADHD. Instead, it seeks to understand how and for whom it works, contributing to the long-term development of individualized, evidence-based neuromodulation strategies for children with attentional difficulties.

The study complies with ethical standards for pediatric research and brain stimulation, and is overseen by the Local Ethical Committee of Al-Farabi Kazakh National University. It is funded by the Ministry of Science and Higher Education of the Republic of Kazakhstan under grant number IRN BR27198099. No U.S. FDA-regulated products are involved.

Being tested
Intermittent Theta Burst Stimulation to Right DLPFC, Sham Intermittent Theta Burst Stimulation
Keywords
Transcranial Magnetic Stimulation, Theta Burst Stimulation, Pediatric Neurostimulation, Neurodevelopmental Disorders, Multimodal Biomarkers, Electrophysiology, Functional Near-Infrared Spectroscopy, Magnetic Resonance Imaging, Genetic Markers, Randomized Controlled Trial, Sham-Controlled Trial, Child Neuropsychology, Attention Deficit Disorder with Hyperactivity, Executive Function, Cognitive Control, Attention Network Test, Prefrontal Cortex Excitability
Medical subject headings
Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intermittent Theta Burst Stimulation to Right DLPFCDevice

    Also called iTBS

    Participants receive intermittent theta burst stimulation (iTBS) applied to the right dorsolateral prefrontal cortex (DLPFC). The protocol consists of 600 pulses delivered in bursts of 3 pulses at 50 Hz, repeated at 5 Hz for 2 seconds, every 10 seconds, over approximately 3 minutes per session. Stimulation is delivered at 80% of the participant's active motor threshold. Ten sessions are administered across two weeks.

  • Sham Intermittent Theta Burst StimulationDevice

    Also called Sham iTBS

    Participants receive sham intermittent theta burst stimulation (iTBS) to the right dorsolateral prefrontal cortex (DLPFC) using a placebo coil. The coil replicates the sound and scalp sensation of active stimulation without generating sufficient magnetic output to alter cortical excitability. Session length, coil placement, and stimulation parameters are matched to the active iTBS condition. To preserve blinding, both participants and administering staff wear earplugs to minimize auditory differences between sham and active coils. This condition serves as a placebo control for evaluating iTBS effects on attention in children with ADHD.

Study groups in NCT07182344
Study groupRoleWhat they receive
Active iTBS to Right DLPFCExperimentalParticipants receive active intermittent theta burst stimulation (iTBS) to the right dorsolateral prefrontal cortex (DLPFC). Each session includes 600 pulses delivered in 2-second trains of 50 Hz bursts (triplets at 5 Hz), repeated every 10 seconds for a total duration of approximately 3 minutes, at 80% of active motor threshold. A total of 10 sessions is administered across two weeks.
Receives: Device: Intermittent Theta Burst Stimulation to Right DLPFC
Sham iTBS (Right DLPFC)Sham comparatorParticipants receive sham stimulation over the right DLPFC using the same coil orientation, session structure, and auditory cues as the active iTBS group, but without magnetic field induction. Ten sham sessions are delivered over two weeks to maintain blinding and control for placebo effects.
Receives: Device: Sham Intermittent Theta Burst Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Executive Attention Efficiency as Measured by the Attention Network Test (ANT)

    Executive attention is measured as the conflict effect (reaction time in incongruent flanker trials - reaction time in congruent flanker trials). Smaller values of reaction time difference (milliseconds, ms) reflect improved conflict resolution and executive control.

    Measured: Baseline and post-intervention (within 7 days of final TMS session)

Secondary outcomes (6)

  1. Change in Event-Related Potentials During ANT (EEG - N2 Component)

    Amplitude of N2 (~200-350 ms) during ANT incongruent vs. congruent trials, reflecting conflict monitoring (µV²/Hz).

    Measured: Baseline and up to 7 days after the final TMS session.

  2. Change in Event-Related Potentials During ANT (EEG - P3 Component)

    Amplitude of P3 (~350-550 ms) during ANT trials, reflecting attentional allocation (µV²/Hz).

    Measured: Baseline and up to 7 days after the final TMS session.

  3. Change in Oscillatory EEG Power During ANT (Theta Band)

    Mean theta-band power (4-7 Hz) over fronto-central electrodes during ANT (µV²/Hz).

    Measured: Baseline and up to 7 days after the final TMS session.

  4. Change in Resting-State Prefrontal Activity - Mean Oxygenation (fNIRS)

    Resting-state functional near-infrared spectroscopy (fNIRS) measurement of mean oxygenated hemoglobin (HbO, µM) in the dorsolateral prefrontal cortex (DLPFC).

    Measured: Baseline and up to 7 days after the final TMS session.

  5. Change in Resting-State Prefrontal Activity - Functional Connectivity (fNIRS)

    Resting-state fNIRS measurement of connectivity indices across DLPFC channels (e.g., correlation coefficients between HbO time series).

    Measured: Baseline and up to 7 days after the final TMS session.

  6. Change in ADHD Symptom Severity (Vanderbilt ADHD Diagnostic Parent Rating Scale, VADPRS)

    Parent-reported Vanderbilt ADHD Diagnostic Parent Rating Scale (VADPRS). The questionnaire includes 47 symptom items scored 0-3 ("Never" to "Very Often"), covering inattention, hyperactivity/impulsivity, oppositional-defiant, conduct, and anxiety/depression domains. It also includes 8 performance/impairment items scored 1-5 ("Excellent" to "Problematic"). Higher symptom scores (0-141) indicate greater severity of ADHD-related behaviors, while higher performance scores indicate worse functioning.

    Measured: Baseline and up to 7 days after the final TMS session.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2025
  2. Study start4 Sep 2025
  3. Primary completionMar 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07182344
Sponsor's protocol ID
2.2.6.2
Other IDs
BR27198099
Status last verified
Aug 2025
First submitted
20 Aug 2025
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD), including demographics, baseline and outcome measures from the Attention Network Task (ANT), SNAP-IV, Vanderbilt ADHD Diagnostic Parent Rating Scale, WISC-V indices, genetic markers (saliva DNA sequencing results limited to specified polymorphisms), structural MRI volumetric data, fNIRS prefrontal oxygenation measures, EEG during ANT, and TMS stimulation parameters, will be shared.

Publications

  • Yen C, Valentine EP, Chiang MC. The Use of Transcranial Magnetic Stimulation in Attention Optimization Research: A Review from Basic Theory to Findings in Attention-Deficit/Hyperactivity Disorder and Depression. Life (Basel). 2024 Feb 29;14(3):329. doi: 10.3390/life14030329.

    PubMed 38541654

  • Weaver L, Rostain AL, Mace W, Akhtar U, Moss E, O'Reardon JP. Transcranial magnetic stimulation (TMS) in the treatment of attention-deficit/hyperactivity disorder in adolescents and young adults: a pilot study. J ECT. 2012 Jun;28(2):98-103. doi: 10.1097/YCT.0b013e31824532c8.

    PubMed 22551775

  • Bussing R, Mason DM, Bell L, Porter P, Garvan C. Adolescent outcomes of childhood attention-deficit/hyperactivity disorder in a diverse community sample. J Am Acad Child Adolesc Psychiatry. 2010 Jun;49(6):595-605. doi: 10.1016/j.jaac.2010.03.006. Epub 2010 May 1.

    PubMed 20494269

  • Poliakova E, Conrad AL, Schieltz KM, O'Brien MJ. Using fNIRS to evaluate ADHD medication effects on neuronal activity: A systematic literature review. Front Neuroimaging. 2023;2:1083036. doi: 10.3389/fnimg.2023.1083036. Epub 2023 Jan 24.

    PubMed 37033327

  • Lundervold AJ, Adolfsdottir S, Halleland H, Halmoy A, Plessen K, Haavik J. Attention Network Test in adults with ADHD--the impact of affective fluctuations. Behav Brain Funct. 2011 Jul 27;7:27. doi: 10.1186/1744-9081-7-27.

    PubMed 21794128

  • Le HT, Honma K, Annaka H, Shunxiang S, Murakami T, Hiraoka T, Nomura T. Effectiveness of Transcranial Magnetic Stimulation on Executive Function, Attention, and Memory in Stroke Patients: A Systematic Review and Meta-Analysis. Cureus. 2024 Dec 6;16(12):e75194. doi: 10.7759/cureus.75194. eCollection 2024 Dec.

    PubMed 39759598

  • Hall CL, Guo B, Valentine AZ, Groom MJ, Daley D, Sayal K, Hollis C. The Validity of the SNAP-IV in Children Displaying ADHD Symptoms. Assessment. 2020 Sep;27(6):1258-1271. doi: 10.1177/1073191119842255. Epub 2019 Apr 16.

    PubMed 30991820

  • Fu B, Zhou X, Zhou X, Li X, Chen Z, Zhang Y, Du Q. Efficacy and Safety of Transcranial Magnetic Stimulation for Attention-Deficit Hyperactivity Disorder: A Systematic Review and Meta-Analysis. Brain Behav. 2025 Jan;15(1):e70246. doi: 10.1002/brb3.70246.

    PubMed 39829146

  • Mihalache D, Mazilu D, Crasovan LC. Linear stability analysis of walking vector solitons. Phys Rev E Stat Phys Plasmas Fluids Relat Interdiscip Topics. 1999 Dec;60(6 Pt B):7504-10. doi: 10.1103/physreve.60.7504.

    PubMed 11970700

  • Cools R, D'Esposito M. Inverted-U-shaped dopamine actions on human working memory and cognitive control. Biol Psychiatry. 2011 Jun 15;69(12):e113-25. doi: 10.1016/j.biopsych.2011.03.028. Epub 2011 May 4.

    PubMed 21531388

  • Cho SS, Ko JH, Pellecchia G, Van Eimeren T, Cilia R, Strafella AP. Continuous theta burst stimulation of right dorsolateral prefrontal cortex induces changes in impulsivity level. Brain Stimul. 2010 Jul;3(3):170-6. doi: 10.1016/j.brs.2009.10.002. Epub 2009 Oct 31.

    PubMed 20633446

  • Chen YH, Liang SC, Sun CK, Cheng YS, Tzang RF, Chiu HJ, Wang MY, Cheng YC, Hung KC. A meta-analysis on the therapeutic efficacy of repetitive transcranial magnetic stimulation for cognitive functions in attention-deficit/hyperactivity disorders. BMC Psychiatry. 2023 Oct 17;23(1):756. doi: 10.1186/s12888-023-05261-2.

    PubMed 37845676

  • Chen SY, Tsou MH, Chen KY, Liu YC, Lin MT. Impact of repetitive transcranial magnetic stimulation on cortical activity: a systematic review and meta-analysis utilizing functional near-infrared spectroscopy evaluation. J Neuroeng Rehabil. 2024 Jun 24;21(1):108. doi: 10.1186/s12984-024-01407-9.

    PubMed 38915003

  • Bidwell LC, Gray JC, Weafer J, Palmer AA, de Wit H, MacKillop J. Genetic influences on ADHD symptom dimensions: Examination of a priori candidates, gene-based tests, genome-wide variation, and SNP heritability. Am J Med Genet B Neuropsychiatr Genet. 2017 Jun;174(4):458-466. doi: 10.1002/ajmg.b.32535.

    PubMed 28512748

  • Barth B, Rohe T, Deppermann S, Fallgatter AJ, Ehlis AC. Neural oscillatory responses to performance monitoring differ between high- and low-impulsive individuals, but are unaffected by TMS. Hum Brain Mapp. 2021 Jun 1;42(8):2416-2433. doi: 10.1002/hbm.25376. Epub 2021 Feb 19.

    PubMed 33605509

Questions about this trial

What is this clinical trial studying?

A study testing Intermittent Theta Burst Stimulation to Right DLPFC in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by Neurolab Plus at 2 sites in Kazakhstan.

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 6 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Kazakhstan. 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?

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Executive Attention Efficiency as Measured by the Attention Network Test (ANT) (time frame: Baseline and post-intervention (within 7 days of final TMS session)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07182344, which also lists 17 linked publications.

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 19 Sep 2025.

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