Evaluating a new treatment for sleep difficulties in children with autism spectrum disorder.

INTERVENTION: The intervention is a planned, personalised treatment that uses individual alpha frequency (IAF) to guide repetitive transcranial magnetic stimulation (rTMS) protocol towards optimising outcomes due to the heterogeneous nature of sleep disorders and an autism spectrum disorder. Electroencephalogram/electrocardiogram (EEG/ECG) conducted by a trained technician (with over two years experience) on the TruScan acquisition software (Deymed diagnostic, s.r.o, Czech Republic) will be used to determine the participant s IAF, stimulation frequency and location. Briefly, EEG/ECG will be conducted under eyes closed conditions, and the recorded time series will be converted to the frequency domain using Fast Fourier Transform (FFT). The stimulating frequency will be determined by identifying the dominant peak frequency with the highest power in the 8‐13Hz range and multiplying it by the higher harmonic frequency (5th to 10th) of the ECG nearest to the dominant peak frequency. The stimulation location will be the brain region with the highest aberrant cortical processes compared to a normative database with equal parameters and measured using the 10‐20 system. The EEG/ECG will be conducted at baseline, posttreatment (post‐completion of a two‐week treatment program) and follow‐up (one month posttreatment) periods of both treatment and control groups. Data from the IAF, stimulation frequency, and location will be used by the trained technician in personalising the rTMS protocol for each participant. The rTMS is a 5‐second stimulation train with pulses to be delivered at the determined stimulation frequency with 28‐second intervals between 32 trains per‐determined cortical location using an MCF‐B65 butterfly coil and Magpro R30 TMS stimulator. The rTMS will be used to CONDITION: Mental Health ‐ Autistic spectrum disorders Neurological ‐ Other neurological disorders Sleep disorder;Autism spectrum disorder; ; Sleep disorder ; Autism spectrum disorder PRIMARY OUTCOME: The primary outcome will be the difference in sleep quality and quantity following IAF‐guided rTMS. This will be assessed as a composite outcome using actigraphy, polysomnography and the children's sleep habit questionnaire. [At baseline, during the intervention (all day of the intervention), after intervention (the day following completion of the treatment program), and follow‐up (a month posttreatment),] INCLUSION CRITERIA: Inclusion criteria include: i. Children with a valid diagnosis of autism spectrum disorder (ASD)(level 2) and sleep disorder and their primary caregivers (Child‐primary caregiver dyad), ii. Meets clinical ASD symptoms based on the clinical cut‐off of >;11 on the Social Communication Questionnaire Lifetime form (40‐item questionnaire measuring ASD symptoms). iii. Participants will include those living within a 50km radius of the clinic ‐ Morayfield, Queensland, Australia. iv. Children who can complete pre‐assessment electroencephalogram and Polysomnography (level 2 home‐based sleep study). SECONDARY OUTCOME: The secondary outcome will be the differences in ASD symptoms following IAF‐guided rTMS. This will be assessed using the primary caregiver‐rated Aberrant Behavioural Checklist. [At baseline, after intervention (the day following completion of the treatment program), and follow‐up (a month posttreatment),] The secondary outcome will be the differences in ASD symptoms following IAF‐guided rTMS. This will be assessed using the primary caregiver‐rated Social Responsive Scale. [At baseline, after intervention (the day following completion of the treatment program), and follow‐up (a month posttreatment),] The secondary outcome will be the differences in the quality of life parameters of the participant following IAF‐guided rTMS. This will be assessed using the primary caregiver‐rated Paediatric Quality of Life Inventory 4.0 (PQoL).[At baseline, after intervention (the day following completion of the treatment program), and follow‐up (a month posttreatment),] The secondary outcomes will be the differences in the quality of life parameters of the primary caregiver following IAF‐guided rTMS. This will be assessed using the self‐reported Short Form 12 item (version 2) Health Survey, ; [At baseline, after intervention (the day following completion of the treatment program), and follow‐up (a month posttreatment),] The secondary outcomes will be the documented reports on safety parameters to the participant following IAF‐guided rTMS. This will be assessed using the NIB tolerability questionnaire. [After intervention (the day following completion of the treatment program) and follow‐up (a month posttreatment),]