Cortical Excitability and Role of Non Invasive Brain Stimulation in ADHD and AUTISM
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-19
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 6-19 years.
ASD trial: DSM-5 diagnosis of ASD confirmed by CARS-2.
ADHD trial: DSM-5 diagnosis of ADHD confirmed by structured interview/CONORS
IQ ≥ 70.
Disqualifiers
Epilepsy or seizure history.
Metallic implants or devices incompatible with TMS.
Severe psychiatric comorbidity (e.g., psychosis).
Inability to tolerate TMS procedures.
Trial design
Design model
Parallel
Treatments tested in this trial
Active repetitive transcranial magnetic stimulation (rTMS)
DeviceActive 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.
Sham repetitive transcranial magnetic stimulation (sham rTMS)
DeviceSham 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.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: ADHD Active rTMSExperimental treatment 1 intervention
Group B: ADHD Sham rTMSSham comparator 1 intervention
Group C: ASD Active rTMSExperimental treatment 1 intervention
Group D: ASD Sham rTMSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in ADHD symptom severity
Mean change in total score on a validated ADHD rating scale (for example, Conners' Parent Rating Scale) from baseline to end of treatment, comparing active rTMS with sham in children and adolescents with ADHD. The primary analysis will use mixed-effects models including fixed effects for group (active vs sham), time, and group × time interaction to estimate the treatment effect on ADHD symptom severity.
Time frame
Baseline (pre-treatment) and within 1 week after completion of the 3-week rTMS/sham treatment course.2
Change in autism symptom severity
Mean change in total score on a validated autism rating scale (for example, Childhood Autism Rating Scale-2 \[CARS-2\]) from baseline to end of treatment, comparing active rTMS with sham in children and adolescents with autism spectrum disorder. The analysis will use mixed-effects models including fixed effects for group (active vs sham), time, and group × time interaction to estimate the treatment effect on autism symptom severity.
Time frame
Baseline (pre-treatment) and within 1 week after completion of the 3-week rTMS/sham treatment course.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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