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NOT YET RECRUITING
NCT07315217
NA

Cortical Excitability and Role of Non Invasive Brain Stimulation in ADHD and AUTISM

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

This double-blind, randomized, sham-controlled clinical trial will evaluate the effects of repetitive transcranial magnetic stimulation (rTMS) on children and adolescents with attention-deficit/hyperactivity disorder (ADHD) or autism spectrum disorder (ASD) and matched healthy controls. Participants aged 6-19 years will be assigned to active or sham rTMS protocols targeting the dorsolateral prefrontal cortex over 3 weeks, with assessment of changes in disorder-specific symptoms and cortical excitability. The study aims to determine the safety, feasibility, and preliminary efficacy of rTMS as a non-invasive neuromodulation approach in pediatric neurodevelopmental disorders.

Official title: Cortical Excitability and Role of Non Invasive Brain Stimulation in ADHD and AUTISM : Double Blind Randomized Clinical Trial

Key Details

Gender

All

Age Range

6 Years - 19 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-01

Completion Date

2027-02

Last Updated

2026-01-02

Healthy Volunteers

Yes

Interventions

DEVICE

Active repetitive transcranial magnetic stimulation (rTMS)

Active repetitive transcranial magnetic stimulation delivered using a figure-of-eight coil. For ADHD, high-frequency 10 Hz rTMS is applied over the right dorsolateral prefrontal cortex at 100-110% resting motor threshold, 1200-1500 pulses per session, 15 sessions over 3 weeks. For ASD, 1 Hz inhibitory rTMS or intermittent theta-burst stimulation is applied over bilateral dorsolateral prefrontal cortex with approximately 1200 pulses per session, 15 sessions over 3 weeks.

DEVICE

Sham repetitive transcranial magnetic stimulation (sham rTMS)

Sham rTMS using the same device and schedule as active treatment, with coil positioning and acoustic cues mimicking stimulation but without delivering effective magnetic pulses. Fifteen sham sessions are administered over 3 weeks for ADHD and ASD participants in the sham arms, in addition to standard clinical care.