Repetitive transcranial magnetic stimulation (rTMS) in autism spectrum disorder: protocol for a multicentre randomised controlled clinical trial
Adam J Guastella,
Ian B Hickie,
Jeffrey M Craig,
Karen Barlow,
Andrew J O Whitehouse,
Karen Caeyenberghs,
Helen Heussler,
Paul B Fitzgerald,
Cherrie Galletly,
Peter G Enticott,
Melissa K Licari,
Nigel C Rogasch,
Christel M Middeldorp,
Scott R Clark,
Ann-Maree Vallence,
Kelsie A Boulton,
Gail A Alvares,
Hakuei Fujiyama,
Melissa Kirkovski,
Natalie T Mills,
Nicole J Rinehart,
Peter H Donaldson,
Talitha C Ford,
Natalia Albein-Urios,
Soukayna Bekkali
Affiliations
Adam J Guastella
Autism Clinic for Translational Research, Brain and Mind Centre, Children’s Hospital Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia
Ian B Hickie
Brain and Mind Centre, Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Camperdown, New South Wales, Australia
Jeffrey M Craig
IMPACT – the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Deakin University, Geelong, Victoria, Australia
Karen Barlow
Child Health Research Centre, The University of Queensland, South Brisbane, Queensland, Australia
Andrew J O Whitehouse
Telethon Kids Institute, Perth, Western Australia, Australia
Karen Caeyenberghs
1 Cognitive Neuroscience Unit, Deakin University, Burwood, Victoria, Australia
Helen Heussler
Children`s Health Queensland Hospital and Health Service, Herston, Queensland, Australia
Paul B Fitzgerald
Central Clinical School, Monash University, Melbourne, Victoria, Australia
Cherrie Galletly
Discipline of Psychiatry, The University of Adelaide, Adelaide, South Australia, Australia
Peter G Enticott
School of Psychology, Deakin University, Geelong, Victoria, Australia
Melissa K Licari
University of Western Australia, Crawley, Western Australia, Australia
Nigel C Rogasch
Discipline of Psychiatry, The University of Adelaide, Adelaide, South Australia, Australia
Christel M Middeldorp
Child Health Research Centre, The University of Queensland, South Brisbane, Queensland, Australia
Scott R Clark
Discipline of Psychiatry, The University of Adelaide, Adelaide, South Australia, Australia
Ann-Maree Vallence
Centre for Molecular Medicine and Innovative Therapeutics, Murdoch University, Murdoch, Western Australia, Australia
Kelsie A Boulton
Clinic for Autism and Neurodevelopment (CAN) research, Brain and Mind Centre, Children’s Hospital Westmead Clinical School, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia
Gail A Alvares
Telethon Kids Institute, Perth, Western Australia, Australia
Hakuei Fujiyama
Discipline of Psychology, Murdoch University, Murdoch, Western Australia, Australia
Melissa Kirkovski
School of Psychology, Deakin University, Geelong, Victoria, Australia
Natalie T Mills
Discipline of Psychiatry, The University of Adelaide, Adelaide, South Australia, Australia
Nicole J Rinehart
School of Psychology, Deakin University, Geelong, Victoria, Australia
Peter H Donaldson
School of Psychology, Deakin University, Geelong, Victoria, Australia
Talitha C Ford
School of Psychology, Deakin University, Geelong, Victoria, Australia
Natalia Albein-Urios
School of Psychology, Deakin University, Geelong, Victoria, Australia
Soukayna Bekkali
School of Psychology, Deakin University, Geelong, Victoria, Australia
Introduction There are no well-established biomedical treatments for the core symptoms of autism spectrum disorder (ASD). A small number of studies suggest that repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation technique, may improve clinical and cognitive outcomes in ASD. We describe here the protocol for a funded multicentre randomised controlled clinical trial to investigate whether a course of rTMS to the right temporoparietal junction (rTPJ), which has demonstrated abnormal brain activation in ASD, can improve social communication in adolescents and young adults with ASD.Methods and analysis This study will evaluate the safety and efficacy of a 4-week course of intermittent theta burst stimulation (iTBS, a variant of rTMS) in ASD. Participants meeting criteria for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition ASD (n=150, aged 14–40 years) will receive 20 sessions of either active iTBS (600 pulses) or sham iTBS (in which a sham coil mimics the sensation of iTBS, but no active stimulation is delivered) to the rTPJ. Participants will undergo a range of clinical, cognitive, epi/genetic, and neurophysiological assessments before and at multiple time points up to 6 months after iTBS. Safety will be assessed via a structured questionnaire and adverse event reporting. The study will be conducted from November 2020 to October 2024.Ethics and dissemination The study was approved by the Human Research Ethics Committee of Monash Health (Melbourne, Australia) under Australia’s National Mutual Acceptance scheme. The trial will be conducted according to Good Clinical Practice, and findings will be written up for scholarly publication.Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12620000890932).
