An interventional study of repetitive Transcranial Magnetic Stimulation in Autism Spectrum Disorder, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment
This study is a 6-week open-label clinical trial involving 20 children aged 6-10 years with autism spectrum disorder. During the study, subjects received repeated transcranial magnetic stimulation（rTMS）intervention at the left primary motor cortex (M1) 5 times per day for 10 days. From the beginning of intervention to the end of 4 weeks after the completion of intervention, the subjects's clinical symptomatology, cognitive psychology, neuroimaging, and adverse events will be followed up.Our purpose is to explore whether rTMS can improve the clinical symptoms of children with autism spectrum disorder in China, and to explore the neurophysiological mechanism of rTMS for autistic children.
Participants will receive continuous theta burst stimulation (cTBS) for a 10-day period (10 sessions). If feasible for the participant, all stimulation sessions will be held at the same time of the day. During this study，participants' clinical symptomatology, cognitive psychology, neuroimaging, and adverse events will be followed up for four times, specifically，before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 20 is below the median of 52 across 1,371 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 222 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive continuous theta burst stimulation (cTBS) for a 10-day period (10 sessions). If feasible for the participant, all stimulation sessions will be held at the same time of the day.
Device: repetitive Transcranial Magnetic Stimulation
A technique that involves the use of electrical coils on the head to generate a brief magnetic field which reaches the cerebral cortex.
Social Response Scale (SRS)
SRS is a questionnaire used to assess the presence and severity of social impairment, with high scores indicating severe symptoms. Change of the SRS from baseline to 3 month after treatment to evaluate the effect of computer social interaction treatment on ASD children.
Time frame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Repetitive Stereotyped Behavior - Revised (RBS-R)
The Repetitive Behaviors Scale - Revised (RBS-R) is a 44-item self-report questionnaire that is used to measure the breadth of repetitive behavior in children, adolescents, and adults with Autism Spectrum disorders. The RBS-R provides a quantitative, continuous measure of the full spectrum of repetitive behaviors. The RBS-R consists of six subscales including: Stereotyped Behavior, Self-injurious Behavior, Compulsive Behavior, Routine Behavior, Sameness Behavior, and Restricted Behavior, that have no overlap of item content.
Time frame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
ADHD Rating Scale
ADHD Rating Scale is the most widely used ADHD screening and treatment monitoring tools.
Time frame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Behavior Rating Inventory of Executive Function(BRIEF)
Specifically the investigators will evaluate the changes in executive function (EF) scores before and after cTBS treatment. The higer scores indicate more impairment in executive function.
Time frame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Childhood Autism Rating Scale (CARS)
CARS is a behaviour-rating scale used to assess the presence and severity of the symptoms of autism spectrum disorder(ASD), with scores ranging from 15 to 60 and high scores indicating severe symptoms. Change of the CARS from baseline to 3 months after treatment to evaluate the effect of tablet computer social interaction treatment on ASD children.
Time frame: Before intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Clinical Efficacy Rating Scale (CGI)
CGI is a scale used to assess the severity of the illness and the global improvement of the patient under intervention.
Time frame: 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Cambridge Neuropsychological Test Automated Battery (CANTAB)
CANTAB tests have demonstrated sensitivity to detecting changes in neuropsychological performance and include tests of working memory, learning and executive function; visual, verbal and episodic memory; attention, information processing and reaction time; social and emotion recognition, decision making and response control.
Time frame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Continuous Operation Test (CPT)
To obtain reliable parameters of behavior, continuous performance tasks (CPTs) are usually used where the subject performs a constant-difficulty task for minutes or tens of minutes without interruptions.
Time frame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Resting State Electroencephalography
There are three main parameters: phase locking value(PLV) , coherence (Coh) and the power spectral density of alpha band (PSD). PLV and Coh are estimated for exploring the functional connectivity between the targeted brain region and the rest regions of brain.
Time frame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Functional Near Infrared Spectroscopy , fNIRS
Head fNIRs is a non-invasive, non-ionizing method for measuring and imaging the functional hemodynamic response to brain activity. It measures changes in hemoglobin (Hb) concentrations within the brain by means of the characteristic absorption spectra of Hb in the near-infrared range. Changes in the head fNIRs results of the subject before and after treatment.
Time frame: Before intervention, 5 days after intervention, immediately after the completion of intervention , and 4 weeks after the completion of intervention
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine