An interventional study of Repetitive Transcranial Magnetic Stimulation in Autism Spectrum Disorder, sponsored by Centre for Addiction and Mental Health. Completed at 1 site in Canada. Open to participants aged 16 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-06.
Sponsored by Centre for Addiction and Mental Health · Not applicable, Interventional, and Treatment
In this study, the investigators will be examining the effects of repetitive transcranial magnetic stimulation (rTMS) on executive function deficits in individuals with autism spectrum disorder. Half of the participants will be chosen by chance to receive active rTMS stimulation while half will be chosen by chance to receive sham rTMS. Sham rTMS will feel the same as active rTMS only there will be no direct brain stimulation. This is necessary to ensure that active rTMS is efficacious in the enhancement of executive function in individuals with autism spectrum disorder. Based on results from a recently published pilot study, the investigators propose that active rTMS treatment will result in a significant improvement in working memory performance compared to sham rTMS treatment.
This study is a randomized, double blind, sham controlled study to evaluate the efficacy of repetitive transcranial magnetic stimulation (rTMS) as a treatment for executive function deficits in individuals with autism spectrum disorder between 16 and 25 years of age. The study duration is approximately 3 months, with the rTMS sessions lasting for 4 weeks, 5 times a week, for about 1 hour each. Several scales will be used to assess for symptom severity and adaptive functioning. Cognition will be assessed using a validated battery.
This study also involves a type of brain imaging known as magnetic resonance imaging (MRI) at the beginning and at the end of the 4 weeks of daily rTMS to better understand the effects of rTMS on brain structure and function. Investigators will measure the size and connections of different parts of the brain to assess brain structure and blood flow while participants are completing some basic tasks to asses brain function.
1,755 studies on the registry are indexed under Autism Spectrum Disorder; 507 are open to participants now.
This study's enrollment of 40 is below the median of 52 across 1,391 interventional studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Centre for Addiction and Mental Health is the lead sponsor of 339 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria Autism Spectrum Disorder (ASD):
Exclusion Criteria (ASD):
Inclusion Criteria (Healthy Controls):
Exclusion Criteria (Healthy Controls):
Active treatment will be delivered at an intensity that is 90% of the resting motor threshold (RMT). Stimulation will be delivered at 20 Hz with 25 simulation trains of 30 stimuli each (i.e., 750 stimuli) and an intertrain interval of 30 sec. Treatment will be applied in sequential order bilaterally to the left and right dorsolateral prefrontal cortex (DLPFC). The order of bilateral stimulation (i.e. right then left or left than right) will be held constant for all 20 treatments. Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Device: Repetitive Transcranial Magnetic Stimulation
Sham stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but with only the side-edge resting on the scalp. The coil will be angled 45 degrees way from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g. contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects. Intervention: Device: Repetitive Transcranial Magnetic Stimulation
Device: Repetitive Transcranial Magnetic Stimulation
rTMS is a non-invasive procedure involving the use of magnetic fields to stimulate nerve cells.
Also known as: MagPro x100 series (Medtronic A/S, Copenhagen, Denmark)
Change in accuracy on the Cambridge Neuropsychological Test Automated Battery (CANTAB) Spatial Working Memory Task
Specifically the investigators will evaluate the changes in spatial working memory scores before and after rTMS treatment.
Time frame: Baseline; Post rTMS (4 weeks after baseline); One month follow up ( 4 weeks after post rTMS); 6 month follow up (post rTMS); One year follow up (post rTMS)
Change in scores on Behaviour Rating Inventory of Executive Functioning (A) (BRIEF) (A)
Specifically the investigators will evaluate the changes in executive function (EF) scores before and after rTMS treatment.
Time frame: Baseline; Post rTMS (4 weeks after baseline); One month follow up ( 4 weeks after post rTMS); 6 month follow up (post rTMS); One year follow up (post rTMS)
Plan to share: No
Ran from Oct 2014 to primary completion in May 2018, 43 months.
Of 801 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 43 months is above that.
Counting every sponsor, half of 825 studies reached it within 25 months; a quarter within 12 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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