Brain Stimulation and Attention Control in Children With ADHD

NCT07182344 | Enrolling By Invitation

• 2 other identifiers: 2.2.6.2BR27198099
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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. 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? 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

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (6)

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

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

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

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

• Change in Oscillatory EEG Power During ANT (Theta Band)

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

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

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

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

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

Other Outcomes (3)

• Correlation of Cortical Thickness (MRI) with Change in ANT Conflict Effect

  MRI obtained once at baseline.

• Correlation of Cortical Volume (MRI) with Change in ANT Conflict Effect

  MRI obtained once at baseline.

• Correlation of Genetic Variant Frequencies with Change in ANT Conflict Effect

  Saliva samples collected once at baseline.

Study Arms (2)

Active iTBS to Right DLPFC

EXPERIMENTAL

Participants 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.

Device: Intermittent Theta Burst Stimulation to Right DLPFC

Sham iTBS (Right DLPFC)

SHAM COMPARATOR

Participants 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.

Device: Sham Intermittent Theta Burst Stimulation

Interventions

Intermittent Theta Burst Stimulation to Right DLPFC DEVICE

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.

Also known as: iTBS

Active iTBS to Right DLPFC

Sham Intermittent Theta Burst Stimulation DEVICE

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.

Also known as: Sham iTBS

Sham iTBS (Right DLPFC)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurolab Plus: lead
• Al-Farabi Kazakh National University (KazNU): collaborator

Study Sites (2)

Neurolab Plus

Almaty, 050000, Kazakhstan

Location

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

Almaty, 050040, Kazakhstan

Location

Related Publications (17)

• 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.

  PMID: 38541654 BACKGROUND

• 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.

  PMID: 22551775 BACKGROUND

• 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.

  PMID: 20494269 BACKGROUND

• 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.

  PMID: 37033327 BACKGROUND

• 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.

  PMID: 21794128 BACKGROUND

• 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.

  PMID: 39759598 BACKGROUND

• 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.

  PMID: 30991820 BACKGROUND

• 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.

  PMID: 39829146 BACKGROUND

• 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.

  PMID: 11970700 BACKGROUND

• 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.

  PMID: 21531388 BACKGROUND

• 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.

  PMID: 20633446 BACKGROUND

• 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.

  PMID: 37845676 BACKGROUND

• 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.

  PMID: 38915003 BACKGROUND

• 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.

  PMID: 28512748 BACKGROUND

• 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.

  PMID: 33605509 BACKGROUND

• Anderson NP, Feldman JA, Kolko DJ, Pilkonis PA, Lindhiem O. National Norms for the Vanderbilt ADHD Diagnostic Parent Rating Scale in Children. J Pediatr Psychol. 2022 Jun 7;47(6):652-661. doi: 10.1093/jpepsy/jsab132.

  PMID: 34986222 BACKGROUND

• Dos Santos Afonso Junior A, Machado-Pinheiro W, Osorio AAC, Seabra AG, Teixeira MCTV, de Araujo Nascimento J, Carreiro LRR. Association between ADHD symptoms and inhibition-related brain activity using functional near-infrared spectroscopy (fNIRS). Neurosci Lett. 2023 Jan 1;792:136962. doi: 10.1016/j.neulet.2022.136962. Epub 2022 Nov 11.

  PMID: 36375626 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors are all blinded to group assignment (active vs. sham TMS). The sham condition mimics the sound and sensation of stimulation without delivering active magnetic pulses, using an identical setup. Randomization and group codes are maintained by an independent administrator and not revealed until after final data analysis. Blinding is used to reduce bias in behavioral, neurophysiological, and questionnaire-based outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 19, 2025
• Study Start: September 4, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified data will be made available within 12 months following publication of the main study results and will remain available for at least 5 years thereafter.
• Access Criteria: Data will be accessible to qualified researchers at academic or medical institutions upon submission of a justified request. Each request will be reviewed by the study steering committee. Approved researchers will sign a data use agreement to ensure compliance with ethical standards, including prohibiting any attempt to re-identify participants. Data will be distributed via a secure repository.

Locations

KA (2)