By InvitationNot Applicable

Brain Stimulation and Attention Control in Children With ADHD

Kazakhstan40 participantsStarted 2025-09-04

Plain-language 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

Who can participate

Age range6 Years – 12 Years

SexALL

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Inclusion Criteria: * 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. Exclusion Criteria: * 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.

What they're measuring

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

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

Trial details

NCT IDNCT07182344

SponsorNeurolab Plus

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03