Repetitive transcranial magnetic stimulation (rTMS) in autism spectrum disorder: protocol for a multicentre randomised controlled clinical trial
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 outcome...
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Language: | English |
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BMJ Publishing Group
2021-07-01
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Series: | BMJ Open |
Online Access: | https://bmjopen.bmj.com/content/11/7/e046830.full |
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doaj-5f55135337104a468eb341ac1dc03a1d |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Adam J Guastella Jeffrey M Craig Karen Barlow Andrew J O Whitehouse Karen Caeyenberghs 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 |
spellingShingle |
Adam J Guastella Jeffrey M Craig Karen Barlow Andrew J O Whitehouse Karen Caeyenberghs 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 Repetitive transcranial magnetic stimulation (rTMS) in autism spectrum disorder: protocol for a multicentre randomised controlled clinical trial BMJ Open |
author_facet |
Adam J Guastella Jeffrey M Craig Karen Barlow Andrew J O Whitehouse Karen Caeyenberghs 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 |
author_sort |
Adam J Guastella |
title |
Repetitive transcranial magnetic stimulation (rTMS) in autism spectrum disorder: protocol for a multicentre randomised controlled clinical trial |
title_short |
Repetitive transcranial magnetic stimulation (rTMS) in autism spectrum disorder: protocol for a multicentre randomised controlled clinical trial |
title_full |
Repetitive transcranial magnetic stimulation (rTMS) in autism spectrum disorder: protocol for a multicentre randomised controlled clinical trial |
title_fullStr |
Repetitive transcranial magnetic stimulation (rTMS) in autism spectrum disorder: protocol for a multicentre randomised controlled clinical trial |
title_full_unstemmed |
Repetitive transcranial magnetic stimulation (rTMS) in autism spectrum disorder: protocol for a multicentre randomised controlled clinical trial |
title_sort |
repetitive transcranial magnetic stimulation (rtms) in autism spectrum disorder: protocol for a multicentre randomised controlled clinical trial |
publisher |
BMJ Publishing Group |
series |
BMJ Open |
issn |
2044-6055 |
publishDate |
2021-07-01 |
description |
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). |
url |
https://bmjopen.bmj.com/content/11/7/e046830.full |
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doaj-5f55135337104a468eb341ac1dc03a1d2021-10-09T08:00:04ZengBMJ Publishing GroupBMJ Open2044-60552021-07-0111710.1136/bmjopen-2020-046830Repetitive transcranial magnetic stimulation (rTMS) in autism spectrum disorder: protocol for a multicentre randomised controlled clinical trialAdam J Guastella0Jeffrey M Craig1Karen Barlow2Andrew J O Whitehouse3Karen Caeyenberghs4Paul B Fitzgerald5Cherrie Galletly6Peter G Enticott7Melissa K Licari8Nigel C Rogasch9Christel M Middeldorp10Scott R Clark11Ann-Maree Vallence12Kelsie A Boulton13Gail A Alvares14Hakuei Fujiyama15Melissa Kirkovski16Natalie T Mills17Nicole J Rinehart18Peter H Donaldson19Talitha C Ford20Natalia Albein-Urios21Soukayna Bekkali22Autism 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, AustraliaIMPACT – the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Deakin University, Geelong, Victoria, AustraliaChild Health Research Centre, The University of Queensland, South Brisbane, Queensland, AustraliaTelethon Kids Institute, Perth, Western Australia, AustraliaSchool of Psychology, Deakin University, Geelong, Victoria, AustraliaCentral Clinical School, Monash University, Melbourne, Victoria, AustraliaDiscipline of Psychiatry, The University of Adelaide, Adelaide, South Australia, AustraliaSchool of Psychology, Deakin University, Geelong, Victoria, AustraliaTelethon Kids Institute, Perth, Western Australia, AustraliaDiscipline of Psychiatry, The University of Adelaide, Adelaide, South Australia, AustraliaChild Health Research Centre, The University of Queensland, South Brisbane, Queensland, AustraliaDiscipline of Psychiatry, The University of Adelaide, Adelaide, South Australia, AustraliaCentre for Molecular Medicine and Innovative Therapeutics, Murdoch University, Murdoch, Western Australia, AustraliaAutism 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, AustraliaTelethon Kids Institute, Perth, Western Australia, AustraliaDiscipline of Psychology, Murdoch University, Murdoch, Western Australia, AustraliaSchool of Psychology, Deakin University, Geelong, Victoria, AustraliaDiscipline of Psychiatry, The University of Adelaide, Adelaide, South Australia, AustraliaSchool of Psychology, Deakin University, Geelong, Victoria, AustraliaSchool of Psychology, Deakin University, Geelong, Victoria, AustraliaSchool of Psychology, Deakin University, Geelong, Victoria, AustraliaSchool of Psychology, Deakin University, Geelong, Victoria, AustraliaSchool of Psychology, Deakin University, Geelong, Victoria, AustraliaIntroduction 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).https://bmjopen.bmj.com/content/11/7/e046830.full |