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ENROLLING BY INVITATION
NCT07182344
NA

Brain Stimulation and Attention Control in Children With ADHD

Sponsor: Neurolab Plus

View on ClinicalTrials.gov

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

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

Key Details

Gender

All

Age Range

6 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-09-04

Completion Date

2026-06

Last Updated

2025-09-19

Healthy Volunteers

No

Interventions

DEVICE

Intermittent Theta Burst Stimulation to Right DLPFC

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.

DEVICE

Sham Intermittent Theta Burst Stimulation

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.

Locations (2)

Neurolab Plus

Almaty, Kazakhstan

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

Almaty, Kazakhstan