Effects of rTMS on Cognitive Functions and Behavior in Individuals With Autism Spectrum Disorder
NCT ID: NCT06524310
Last Updated: 2025-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
35 participants
INTERVENTIONAL
2024-07-20
2025-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Therapeutic Intervention Effects of rTMS on Children With Autism Spectrum Disorder
NCT05140356
Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial
NCT05238298
Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder
NCT04242355
Transcranial Magnetic Stimulation for Evaluation and Treatment of Repetetive Behaviors in Autism
NCT01983189
Treatment to Promote Self-regulation in Children With Autism Spectrum Disorder
NCT05235919
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Autism spectrum disorder (ASD) is a complex neurodevelopmental disorder. Core ASD symptoms include impairments in social communication and restricted and repetitive behaviors, interests, and activities. ASD may also present with secondary signs, including hyperactivity, self-injury, and co-occurrence of some psychiatric conditions, e.g., anxiety and major depression. The symptoms of ASD are persistent and typically appear during the first three years of life. It can be recognized and clinically evident in early childhood.
In most cases, but not all, ASD symptoms might follow a steady course without remission. However, deficits and impairment in social skills and behavioral patterns may not be noticed and diagnosed as symptoms of ASD until the child faces significant life demands such as social, educational, and occupational tasks. Moreover, this functional limitation may vary among persons with ASD and could develop over time.
In the past 50 years, ASD's description has changed from a rare disease of childhood-onset to a well-publicized, advocated, and researched lifelong condition, recognized as relatively common and very heterogeneous. Since the 1970s, several studies have reported increased ASD cases. The report documented that the male/female ratio is approximately 4 per 1. According to the Centers for Disease Control, the prevalence of ASD increased from 1 in 80 (1.25%) in 2011-2013 to 1 in 31 children (3.2%) aged 8 years, and the corresponding figure for the whole of the United States in 2022 was 8 and 9. In the Gulf countries, systematic review studies of the epidemiology of autism revealed a prevalence ranging from 1.4 to 29/10,000 persons. In a study in Taif, Saudi Arabia, the estimated prevalence of autism in primary school children aged 7-12 years was 0.035%. Reviews of the literature have revealed no recent prevalence statistics for children with autism/ASD in Saudi Arabia. The Saudi Ministry of Health has indicated that one in every 160 children has an ASD.
ASDs are a financial, emotional, and social burden. An autistic child's care causes more emotional burden to the parents than that of parents, compared to that of parents taking care of terminally ill children.
Social cognition is a broad term that describes cognitive processes related to perceiving, understanding, and implementing linguistic, auditory, visual, and physical cues that communicate emotional and interpersonal information. It is also defined as the perception of others, the perception of self, and interpersonal knowledge. It's the ability to understand, perceive, and interpret information about others and ourselves in a social context. It includes a wide range of processes that allow people to perceive and interpret rapidly changing social information and respond appropriately to social stimuli quickly, effortlessly, and flexibly. Also, social cognition ability gives meaning to the actions of others.
Assessment of social cognition, primarily focusing on four key domains, such as theory of mind (ToM), emotional empathy, and social perception and behavior, has been increasingly evaluated in clinical settings, given the potential implications of impairments of these skills for therapeutic decision-making. Cognitive impairment is defined as when a person has trouble remembering, learning new things, concentrating, or making decisions that affect their everyday life. The common signs of cognitive impairment may include loss of memory. Asking the same question frequently or repeating the same story over and over, unable to recognize familiar people or places, having trouble exercising judgment, such as knowing what to do in an emergency, changes in mood or behavior, difficulty in vision, difficulty planning or carrying out tasks, such as following a recipe or keeping track of monthly bills.
Studies showed that alterations in social cognition ability were associated with autism, autism severity, and autistic traits. Impairments in social cognition are often highlighted as a potential mechanism underlying social disability in autism spectrum disorder. Different social skills programs have been developed for autistic adults based on the assumption that improving social understanding and ability will improve functional outcomes.
Transcranial magnetic stimulation (TMS) is one method used to deliver electrical stimuli through the scalp in conscious humans. Generally, single-pulse TMS (including paired-pulse TMS) is used to explore brain functioning. In contrast, repetitive TMS (rTMS) is used to induce changes in brain activity that can last beyond the stimulation period. Therefore, TMS and rTMS are indirect and non-invasive methods to induce excitability changes in the motor cortex via a wire coil, generating a magnetic field that passes through the scalp. TMS Non-invasive TMS of the motor cortex leads to a twitch in the target muscle, evoking motor-evoked potential (MEP) on electromyography. As per the literature, TMS might help regulate gamma oscillations, reduce behavioral symptoms, and normalize executive and autonomic dysfunction signs. TMS is a valuable technique for assessing the underlying neurophysiology associated with several neuropathologies. It is a unique tool for establishing potential neural mechanisms responsible for disease progression. Recently, rTMS has been advanced as a potential therapeutic technique to treat selected neurologic disorders. Such neurological disorders include Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis, and multiple sclerosis.
Moreover, worldwide, multiple studies have repeatedly demonstrated that TMS has antidepressant effects more significantly than sham treatment and that these effects are clinically meaningful. For diagnostic uses, TMS is a potential diagnostic tool in movement disorders. TMS is used worldwide and represents a novel technique with both diagnostic and therapeutic potential. TMS is used to study cortical excitability and intracortical inhibition and investigate cortical and cortico-spinal plasticity mechanisms implicated in ASD pathophysiology. Published studies showing promising results concluded that specific rTMS protocols targeting particular regions of the cortex might lead to improvement in specific behavioral deficits in some individuals with ASD; both the investigative and therapeutic results have been mixed. rTMS and other electrical stimulation devices can modulate the brain's functioning in either a facilitatory or suppressive manner and, when applied over several sessions, can have an additive effect lasting several months. If theories are correct that cortical mechanisms of excitability, connectivity, and plasticity are abnormal in ASD, then rTMS can modulate these mechanisms. Overall, in the hands of trained technicians, rTMS might have great potential as both a diagnostic and therapeutic tool for ASD.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
active rTMS group
Male and female ASD individuals aged between 5 and 11 years old who have been diagnosed with ASD. They should have a confirmed clinical diagnosis according to the DSM-5. This will be verified by a diagnostic report or direct communication with the diagnosing clinician. Also, with normal hearing based on past hearing screens. Exclusion criteria to ensure participant safety for the rTMS intervention and included: (1) a history of seizures or epileptiform activity; (2) the presence of any metallic implants within the cranium; (3) a history of significant head trauma or loss of consciousness; and (4) the presence of implanted electronic medical devices (e.g., pacemakers, cochlear implants). All participants in both study groups did not stop their medical or behavioral therapy for ASD. However, participants will be instructed to have a consistent medication regimen or behavioral treatment for at least one month before enrollment and throughout the trial.
Stimulation with low frequency rTMS at 1 Hz
Stimulation with low-frequency rTMS at 1 Hz with 90% MT will be applied with a total of 180 pulses each time, which contains 18 trains with ten pulses and an interval of 20 s between any two adjacent trains. The TMS treatment course will be administered twice per week for 9 weeks; the first six treatments will be over the left DLPFC, the second six sessions will be over the right DLPFC, and the remaining six sessions will be placed on the bilateral DLPFC stimulation.
wait-list-control group
Male and female ASD individuals aged between 5 and 11 years old who have been diagnosed with ASD. They should have a confirmed clinical diagnosis according to the DSM-5. This will be verified by a diagnostic report or direct communication with the diagnosing clinician. Also, with normal hearing based on past hearing screens. Exclusion criteria to ensure participant safety for the rTMS intervention and included: (1) a history of seizures or epileptiform activity; (2) the presence of any metallic implants within the cranium; (3) a history of significant head trauma or loss of consciousness; and (4) the presence of implanted electronic medical devices (e.g., pacemakers, cochlear implants). All participants in both study groups did not stop their medical or behavioral therapy for ASD. However, participants will be instructed to have a consistent medication regimen or behavioral treatment for at least one month before enrollment and throughout the trial.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Stimulation with low frequency rTMS at 1 Hz
Stimulation with low-frequency rTMS at 1 Hz with 90% MT will be applied with a total of 180 pulses each time, which contains 18 trains with ten pulses and an interval of 20 s between any two adjacent trains. The TMS treatment course will be administered twice per week for 9 weeks; the first six treatments will be over the left DLPFC, the second six sessions will be over the right DLPFC, and the remaining six sessions will be placed on the bilateral DLPFC stimulation.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* age between 5 and 11 years old
* diagnosed with ASD on prior clinical assessment using the American Psychiatric Association's DSM-V criteria and corroborated by assessment using the Autism Diagnostic Observation Schedule (ADOS).
* Normal hearing ability based on past hearing screens.
* Participation will be limited to higher functioning (intelligence quotient \[IQ\] \>70) to maximize successful completion of tested paradigms, maintain alertness/attention, furthermore, the ability to follow instructions.
Exclusion Criteria
* Any individual with a previous Hx. Of head injuries
* Any individual has been diagnosed with psychiatric illness, including ADHD, depression, psychosis, bipolar disorder, anxiety disorders, or OCD.
* Individuals using a combination of Psychotropic Medications known for their significant seizure threshold lowering potential, for example, and not as a limitation: Bupropion, Citalopram, Duloxetine, Fluoxetine, Fluvoxamine, Mirtazapine, Paroxetine, Sertraline, Venlafaxine, Tricyclics, Olanzapine, Quetiapine, Aripiprazole, Ziprasidone, and Risperidone.
* The presence of metallic objects, e.g., cranium clips or implanted biomedical devices.
5 Years
11 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
King Saud University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hayfa Ali Alghabban
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
HAYFA A ALGHABBAN, MD,MSc
Role: PRINCIPAL_INVESTIGATOR
Department of physiology, collage of Medicine, King Saud University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Physiology, Autism Research and Treatment Center (ARTC), King Saud University Medical City (KSUMC)/Collage of Medicine, King Saud University
Riyadh, Riyadh Region, Saudi Arabia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lewis DA, Hashimoto T, Volk DW. Cortical inhibitory neurons and schizophrenia. Nat Rev Neurosci. 2005 Apr;6(4):312-24. doi: 10.1038/nrn1648.
Baruth JM, Casanova MF, El-Baz A, Horrell T, Mathai G, Sears L, Sokhadze E. Low-Frequency Repetitive Transcranial Magnetic Stimulation (rTMS) Modulates Evoked-Gamma Frequency Oscillations in Autism Spectrum Disorder (ASD). J Neurother. 2010 Jul 1;14(3):179-194. doi: 10.1080/10874208.2010.501500.
Oberman LM, Rotenberg A, Pascual-Leone A. Use of transcranial magnetic stimulation in autism spectrum disorders. J Autism Dev Disord. 2015 Feb;45(2):524-36. doi: 10.1007/s10803-013-1960-2.
Regier DA, Kuhl EA, Kupfer DJ. The DSM-5: Classification and criteria changes. World Psychiatry. 2013 Jun;12(2):92-8. doi: 10.1002/wps.20050.
Kaat AJ, Gadow KD, Lecavalier L. Psychiatric symptom impairment in children with autism spectrum disorders. J Abnorm Child Psychol. 2013 Aug;41(6):959-69. doi: 10.1007/s10802-013-9739-7.
Fakhoury M. Autistic spectrum disorders: A review of clinical features, theories and diagnosis. Int J Dev Neurosci. 2015 Jun;43:70-7. doi: 10.1016/j.ijdevneu.2015.04.003. Epub 2015 Apr 8.
Battle DE. Diagnostic and Statistical Manual of Mental Disorders (DSM). Codas. 2013;25(2):191-2. doi: 10.1590/s2317-17822013000200017. No abstract available.
Blumberg SJ, Bramlett MD, Kogan MD, Schieve LA, Jones JR, Lu MC. Changes in prevalence of parent-reported autism spectrum disorder in school-aged U.S. children: 2007 to 2011-2012. Natl Health Stat Report. 2013 Mar 20;(65):1-11, 1 p following 11.
Charman T, Pickles A, Chandler S, Wing L, Bryson S, Simonoff E, Loucas T, Baird G. Commentary: Effects of diagnostic thresholds and research vs service and administrative diagnosis on autism prevalence. Int J Epidemiol. 2009 Oct;38(5):1234-8; author reply 1243-4. doi: 10.1093/ije/dyp256. Epub 2009 Sep 7. No abstract available.
Samsam M, Ahangari R, Naser SA. Pathophysiology of autism spectrum disorders: revisiting gastrointestinal involvement and immune imbalance. World J Gastroenterol. 2014 Aug 7;20(29):9942-51. doi: 10.3748/wjg.v20.i29.9942.
Amr M, Bu Ali W, Hablas H, Raddad D, El-Mehesh F, El-Gilany AH, Al-Shamy H. Sociodemographic factors in Arab children with Autism Spectrum Disorders. Pan Afr Med J. 2012;13:65. Epub 2012 Nov 26.
Developmental Disabilities Monitoring Network Surveillance Year 2010 Principal Investigators; Centers for Disease Control and Prevention (CDC). Prevalence of autism spectrum disorder among children aged 8 years - autism and developmental disabilities monitoring network, 11 sites, United States, 2010. MMWR Surveill Summ. 2014 Mar 28;63(2):1-21.
Christensen DL, Baio J, Van Naarden Braun K, Bilder D, Charles J, Constantino JN, Daniels J, Durkin MS, Fitzgerald RT, Kurzius-Spencer M, Lee LC, Pettygrove S, Robinson C, Schulz E, Wells C, Wingate MS, Zahorodny W, Yeargin-Allsopp M; Centers for Disease Control and Prevention (CDC). Prevalence and Characteristics of Autism Spectrum Disorder Among Children Aged 8 Years--Autism and Developmental Disabilities Monitoring Network, 11 Sites, United States, 2012. MMWR Surveill Summ. 2016 Apr 1;65(3):1-23. doi: 10.15585/mmwr.ss6503a1.
Salhia HO, Al-Nasser LA, Taher LS, Al-Khathaami AM, El-Metwally AA. Systemic review of the epidemiology of autism in Arab Gulf countries. Neurosciences (Riyadh). 2014 Oct;19(4):291-6.
Inglese MD, Elder JH. Caring for children with autism spectrum disorder. Part I: prevalence, etiology, and core features. J Pediatr Nurs. 2009 Feb;24(1):41-8. doi: 10.1016/j.pedn.2007.12.006. Epub 2008 Jun 13.
Friedman S, Samuelian JC, Lancrenon S, Even C, Chiarelli P. Three-dimensional structure of the Hospital Anxiety and Depression Scale in a large French primary care population suffering from major depression. Psychiatry Res. 2001 Nov 30;104(3):247-57. doi: 10.1016/s0165-1781(01)00309-2.
Beer JS, Ochsner KN. Social cognition: a multi level analysis. Brain Res. 2006 Mar 24;1079(1):98-105. doi: 10.1016/j.brainres.2006.01.002. Epub 2006 Feb 28.
Klomjai W, Katz R, Lackmy-Vallee A. Basic principles of transcranial magnetic stimulation (TMS) and repetitive TMS (rTMS). Ann Phys Rehabil Med. 2015 Sep;58(4):208-213. doi: 10.1016/j.rehab.2015.05.005. Epub 2015 Aug 28.
Casanova MF, Sokhadze EM, Casanova EL, Opris I, Abujadi C, Marcolin MA, Li X. Translational Neuroscience in Autism: From Neuropathology to Transcranial Magnetic Stimulation Therapies. Psychiatr Clin North Am. 2020 Jun;43(2):229-248. doi: 10.1016/j.psc.2020.02.004. Epub 2020 Apr 8.
Related Links
Access external resources that provide additional context or updates about the study.
Prevalence and clinical characteristics of autism spectrum disorders in school-age children in Taif- KSA
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
rTMS_ASD_SA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.