An interventional study of Active cTBS and Sham in Executive Dysfunction and ASD, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Status unknown at 1 site in China. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-01-23.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment
In this study, the investigators will explore the effects of repetitive transcranial magnetic stimulation (rTMS) on executive function deficits in high function autism spectrum disorder. Half of the participants will be chosen by chance to receive continuous theta burst stimulation (cTBS) while the other half will be chosen by chance to receive sham stimulation. And finally the sham group individuals also receive cTBS. Based on results from a recent unpublished pilot data, the investigators propose that cTBS treatment will induce a significant improvement in executive function performance compared to sham treatment.
This study is a randomized, sham controlled study to evaluate the efficacy of cTBS as a treatment for executive function deficits in individuals with autism spectrum disorder between 6 and 16 years of age. The study duration is approximately 1 months, with the cTBS sessions lasting for 4 weeks, 5 times a week, for about 20min each. Several scales will be used to assess for symptom severity and adaptive functioning. The executive function will be evaluated by Behaviour Rating Inventory of Executive Functioning (BRIEF) questionnaire. Cognition will be assessed using functional near - infrared spectroscopy (fNIRS).
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 daily cTBS to better understand the effects of cTBS 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.
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:
Active cTBS treatment will be delivered at an intensity that is 70% of the resting motor threshold (RMT). cTBS consist of bursts of 3 magnetic pulses at 30 Hz repeating every 200 ms for 300 pulses. cTBS repeat twice with 15 min interval. Treatment will be applied in central suleus.
Device: Active cTBS
Sham rTMS 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.
Device: Sham
Active cTBS treatment will be delivered at an intensity that is 70% of the resting motor threshold (RMT). cTBS consist of bursts of 3 magnetic pulses at 30 Hz repeating every 200 ms for 300 pulses. cTBS will be repeated twice with 15 min interval. The cTBS sessions last for 4 weeks, 5 times a week. Treatment will be applied to central suleus.
Also known as: magstim Rapid2 (Magstim Company Ltd. UK)
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.
Also known as: magstim Rapid2 (Magstim Company Ltd. UK)
Change in scores on Behaviour Rating Inventory of Executive Functioning (BRIEF)
Specifically the investigators will evaluate the changes in executive function (EF) scores before and after cTBS treatment.
Time frame: Baseline; Post cTBS (4 weeks after baseline
Change in scores, reaction time and brain blood flow on the Working Memory Task by fNIRS
Specifically the investigators will evaluate the changes in spatial working memory scores, reaction time and brain blood flow before and after cTBS treatment.
Time frame: Baseline; Post cTBS (4 weeks after baseline)
Change in size and connections of different parts of the brain to assess brain structure and blood flow by functional magnetic resonance imaging (fMRI)
Specifically the investigators will evaluate the change in size and connections of different parts of the brain to assess brain structure and blood flow by fMRI before and after cTBS treatment.
Time frame: Baseline; Post cTBS (4 weeks after baseline)
Plan to share: No
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine