Cortical ExcitabilityNCT07315217
Cortical Excitability and Role of Non Invasive Brain Stimulation in ADHD and AUTISM
A study testing Active repetitive transcranial magnetic stimulation (rTMS) in people with Cortical Excitability and Brain Stimulation, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Cortical Excitability, Brain Stimulation, ADHD
- What is being tested?
- Active repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- Epilepsy or seizure history.
- Metallic implants or devices incompatible with TMS.
- Severe psychiatric comorbidity (e.g., psychosis).
- Inability to tolerate TMS procedures.
About this study
Official title: Cortical Excitability and Role of Non Invasive Brain Stimulation in ADHD and AUTISM : Double Blind Randomized Clinical 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.
Read the detailed description
Altered cortical excitability and imbalance between excitation and inhibition have been reported in both ADHD and ASD, suggesting that non-invasive brain stimulation may modulate underlying pathophysiology. This study comprises two parallel, double-blind, sham-controlled rTMS trials in children and adolescents aged 6-19 years with ADHD or ASD and age- and sex-matched healthy controls. In the ADHD cohort, high-frequency 10 Hz rTMS will be delivered over the right dorsolateral prefrontal cortex, whereas in the ASD cohort low-frequency 1 Hz or intermittent theta-burst rTMS will be delivered over bilateral dorsolateral prefrontal cortex, each for 15 sessions over 3 weeks. Sham stimulation will mimic sound and procedure without effective magnetic pulses.
Cortical excitability will be assessed using single- and paired-pulse TMS measures (such as resting motor threshold, short-interval intracortical inhibition, long-interval intracortical inhibition, cortical silent period, and transcallosal inhibition). Blood samples will be collected to measure dopamine and brain-derived neurotrophic factor as potential neurochemical correlates. Primary clinical outcomes are changes in validated ADHD and ASD symptom rating scales, with secondary outcomes including changes in cortical excitability indices, biomarker levels, and safety/tolerability events. Data will be collected in a secure database and analyzed with mixed-effects models to estimate treatment effects and generate effect-size estimates to inform future definitive trials of rTMS in pediatric neurodevelopmental disorders.
- Conditions
- Cortical Excitability, Brain Stimulation, ADHD, Autism
- Being tested
- Active repetitive transcranial magnetic stimulation (rTMS), Sham repetitive transcranial magnetic stimulation (sham rTMS)
- Keywords
- Cortical excitability, non invasive brain stimulation, ADHD, Autism
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active repetitive transcranial magnetic stimulation (rTMS)Device
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 repetitive transcranial magnetic stimulation (sham rTMS)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| ADHD Active rTMS | Experimental | Children 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. Receives: Device: Active repetitive transcranial magnetic stimulation (rTMS) |
| ADHD Sham rTMS | Sham comparator | Children 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. Receives: Device: Sham repetitive transcranial magnetic stimulation (sham rTMS) |
| ASD Active rTMS | Experimental | Children 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. Receives: Device: Active repetitive transcranial magnetic stimulation (rTMS) |
| ASD Sham rTMS | Sham comparator | Children 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. Receives: Device: Sham repetitive transcranial magnetic stimulation (sham rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (pre-treatment) and within 1 week after completion of the 3-week rTMS/sham treatment course.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study startJan 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cortical ExcitabilityStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amaal Emad Khairy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315217
- Sponsor's protocol ID
- Brain Stimulation in ADHD/ASD
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Excitability and Role of Non Invasive Brain Stimulation in ADHD and AUTISM : Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07315217
- Acronym / sponsor ID
- Brain Stimulation in ADHD/ASD
- Conditions
- Cortical Excitability, Brain Stimulation, ADHD, Autism
- Keywords
- Cortical excitability, non invasive brain stimulation, ADHD, Autism
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Altered cortical excitability and imbalance between excitation and inhibition have been reported in both ADHD and ASD, suggesting that non-invasive brain stimulation may modulate underlying pathophysiology. This study comprises two parallel, double-blind, sham-controlled rTMS trials in children and adolescents aged 6-19 years with ADHD or ASD and age- and sex-matched healthy controls. In the ADHD cohort, high-frequency 10 Hz rTMS will be delivered over the right dorsolateral prefrontal cortex, whereas in the ASD cohort low-frequency 1 Hz or intermittent theta-burst rTMS will be delivered over bilateral dorsolateral prefrontal cortex, each for 15 sessions over 3 weeks. Sham stimulation will mimic sound and procedure without effective magnetic pulses.
Cortical excitability will be assessed using single- and paired-pulse TMS measures (such as resting motor threshold, short-interval intracortical inhibition, long-interval intracortical inhibition, cortical silent period, and transcallosal inhibition). Blood samples will be collected to measure dopamine and brain-derived neurotrophic factor as potential neurochemical correlates. Primary clinical outcomes are changes in validated ADHD and ASD symptom rating scales, with secondary outcomes including changes in cortical excitability indices, biomarker levels, and safety/tolerability events. Data will be collected in a secure database and analyzed with mixed-effects models to estimate treatment effects and generate effect-size estimates to inform future definitive trials of rTMS in pediatric neurodevelopmental disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ADHD Active rTMS | Experimental | Device: Active repetitive transcranial magnetic stimulation (rTMS)Children 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 comparator | Device: Sham repetitive transcranial magnetic stimulation (sham rTMS)Children 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 | Experimental | Device: Active repetitive transcranial magnetic stimulation (rTMS)Children 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 comparator | Device: Sham repetitive transcranial magnetic stimulation (sham rTMS)Children 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. |
Who may qualify
- Ages
- 6 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- Epilepsy or seizure history.
- Metallic implants or devices incompatible with TMS.
- Severe psychiatric comorbidity (e.g., psychosis).
- Inability to tolerate TMS procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | ADHD Active rTMS, ASD Active rTMS |
| 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. | Device | ADHD Sham rTMS, ASD Sham rTMS |
Primary outcome
Change in ADHD symptom severity
Time frame: Baseline (pre-treatment) and within 1 week after completion of the 3-week rTMS/sham treatment course.
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.
Change in autism symptom severity
Time frame: Baseline (pre-treatment) and within 1 week after completion of the 3-week rTMS/sham treatment course.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Active repetitive transcranial magnetic stimulation (rTMS) in people with Cortical Excitability and Brain Stimulation, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ADHD symptom severity (time frame: Baseline (pre-treatment) and within 1 week after completion of the 3-week rTMS/sham treatment course.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.