None listed
Conditions
Brief summary
There are no validated biomedical interventions for core social symptoms in autism spectrum disorder (ASD). Repetitive transcranial magnetic stimulation (rTMS) has been established as a safe, effective, and targeted technique for a range of brain-based disorders, including depression, migraine, and obsessive-compulsive disorder. While it has been trialled with some success in ASD, this work has been limited by small sample sizes, the heterogeneity of ASD, and less rigorous study designs. Young adults with ASD (aged 14-40, n = 150) will undergo four weeks (20 sessions) of either active or sham (i.e., placebo) rTMS to the right temporoparietal junction (rTPJ). The rTPJ is a key node of the "social brain," and it is underactive and underconnected in people with ASD. Participants will initially undergo a structural magnetic resonance imaging (sMRI) brain scan to allow accurate targeting of the rTMS coil. There will be five sites (Brisbane, Sydney, Melbourne, Adelaide, Perth), with each enrolling 30 participants (15 active, 15 sham). Assessments will be conducted at various points before and up to 6 months after treatment. Both participants and those conducting assessments will be blind to treatment condition. Mixed model analyses will be used to compare active and sham conditions across the assessment timepoints. If successful, this work will establish a first biomedical intervention for ASD, which will result in improved quality of life, participation, and mental health for the estimate 1 in 59 people affected.
Interventions
Intermittent theta burst stimulation (iTBS) to right temporoparietal junction (rTPJ). iTBS is a form of repetitive transcranial magnetic stimulation (rTMS), which is a non-invasive brain stimulation technique. It involves the introduction of weak electrical current in the brain, which is achieved by delivering powerful but brief magnetic pulses to the scalp with a plastic-coated metallic coil.
rTMS will be administered each consecutive weekday for a four-week period (e.g., 20 treatments in tota
Intermittent theta burst stimulation (iTBS) to right temporoparietal junction (rTPJ). iTBS is a form of repetitive transcranial magnetic stimulation (rTMS), which is a non-invasive brain stimulation technique. It involves the introduction of weak electrical current in the brain, which is achieved by delivering powerful but brief magnetic pulses to the scalp with a plastic-coated metallic coil. rTMS will be administered each consecutive weekday for a four-week period (e.g., 20 treatments in total). The site of stimulation (i.e., where the coil will be positioned) will be determined by co-registering the participant’s head to their structural magnetic resonance imaging (MRI) brain scan, and determining the scalp position that sits over the target brain region (rTPJ). Each iTBS treatment will last for 3 minutes and 20 seconds. Including setup time, each iTBS treatment is expected to take approximately 10 minutes. TBS will be delivered at an intensity equivalent to 70% of the participant’s “resting motor threshold” (RMT), which is the minimum stimulator intensity required to produce a discernable hand-muscle response following a single TMS pulse delivered to the primary motor cortex. In terms of stimulation frequency, iTBS involves the administration of 3 TMS pulses at 50Hz, repeated 5 times per second, for 2 seconds, followed by an 8 second rest. This is repeated until a total of 600 pulses have been delivered. Treating staff will use a standardised treatment form to monitor adherence (e.g., number of sessions attended, percentage of protocol delivered).
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
14 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
• Aged between14-40 years • Diagnosed with autism spectrum disorder (ASD) based on DSM-5 criteria, and confirmed via Autism Diagnostic Observation Schedule – Second Edition (ADOS-2)
Exclusion criteria
• History of seizure/s or epilepsy • History of serious head injury • Contraindication to magnetic resonance imaging (MRI) • Formal verbal intelligence quotient VIQ assessment <55, as determined by Wechsler Abbreviated Scale of Intelligence (WASI-2) or another standardised cognitive assessment • Comorbid neurological or psychiatric diagnosis not commonly associated with ASD (e.g., psychosis) • Unstable medical condition • Unstable medication regime, or medication contraindicated for TMS • Substance use/abuse disorder • Concurrent treatment targeting social communication • Evidence of significant epileptiform activity on EEG (e.g., seizures on EEG, runs of epileptiform discharges)
Outcome results
None listed