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 range

6 Years – 12 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More ADHD - Attention Deficit Disorder With Hyperactivity trials