Cortical Excitability and Role of Non Invasive Brain Stimulation in ADHD and AUTISM
1 other identifier
interventional
80
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2025
CompletedStudy Start
First participant enrolled
January 1, 2026
CompletedFirst Posted
Study publicly available on registry
January 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2027
January 2, 2026
December 1, 2025
1 year
December 18, 2025
December 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline (pre-treatment) and within 1 week after completion of the 3-week rTMS/sham treatment course.
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.
Baseline (pre-treatment) and within 1 week after completion of the 3-week rTMS/sham treatment course.
Study Arms (4)
ADHD Active rTMS
EXPERIMENTALChildren and adolescents with ADHD receive high-frequency rTMS over the right dorsolateral prefrontal cortex (10 Hz, 1200-1500 pulses per session, 100-110% of resting motor threshold) for 15 sessions over 3 weeks in addition to standard care.
ADHD Sham rTMS
SHAM COMPARATORChildren and adolescents with ADHD receive sham rTMS using the same session schedule and procedures as the active ADHD rTMS arm, with coil positioning and sound mimicking stimulation but without effective magnetic pulses, plus standard care.
ASD Active rTMS
EXPERIMENTALChildren and adolescents with autism spectrum disorder receive low-frequency (1 Hz) or intermittent theta-burst rTMS over bilateral dorsolateral prefrontal cortex (about 1200 pulses per session) for 15 sessions over 3 weeks, according to the protocol and ethical approval, plus standard care.
ASD Sham rTMS
SHAM COMPARATORChildren and adolescents with autism spectrum disorder receive sham rTMS over bilateral dorsolateral prefrontal cortex with identical session number and duration as the active ASD rTMS arm, but without effective stimulation, plus standard care.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- Stable medication for ≥4 weeks (if any).
You may not qualify if:
- Epilepsy or seizure history.
- Metallic implants or devices incompatible with TMS.
- Severe psychiatric comorbidity (e.g., psychosis).
- Inability to tolerate TMS procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident at Neuropsychiatry Department, Assiut University
Study Record Dates
First Submitted
December 18, 2025
First Posted
January 2, 2026
Study Start
January 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
February 1, 2027
Last Updated
January 2, 2026
Record last verified: 2025-12