Feasibility, safety, and efficacy of high-dose intermittent theta burst stimulation in children with autism spectrum disorder: study protocol for a pilot randomized sham-controlled trial
BackgroundAutism spectrum disorders (ASD) are common neurodevelopmental disorders, mainly caused by disrupted excitation/inhibition balance and synaptic plasticity. Intermittent theta burst stimulation (iTBS) is a variant of excitatory repetitive transcranial magnetic stimulation, inducing long-term...
Saved in:
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2025-03-01
|
| Series: | Frontiers in Psychiatry |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fpsyt.2025.1549982/full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850062455044046848 |
|---|---|
| author | Junzi Long Junzi Long Junzi Long Maoyuan Niu Maoyuan Niu Xingxing Liao Xingxing Liao Xingxing Liao Kaiyue Han Kaiyue Han Jiarou Chen Jiarou Chen Wenlong Su Xianna Wang Jianjun Liu Yan Zhang Hao Zhang Hao Zhang Hao Zhang Hao Zhang Hao Zhang |
| author_facet | Junzi Long Junzi Long Junzi Long Maoyuan Niu Maoyuan Niu Xingxing Liao Xingxing Liao Xingxing Liao Kaiyue Han Kaiyue Han Jiarou Chen Jiarou Chen Wenlong Su Xianna Wang Jianjun Liu Yan Zhang Hao Zhang Hao Zhang Hao Zhang Hao Zhang Hao Zhang |
| author_sort | Junzi Long |
| collection | DOAJ |
| description | BackgroundAutism spectrum disorders (ASD) are common neurodevelopmental disorders, mainly caused by disrupted excitation/inhibition balance and synaptic plasticity. Intermittent theta burst stimulation (iTBS) is a variant of excitatory repetitive transcranial magnetic stimulation, inducing long-term potentiation-like plasticity. In recent years, there has been a growing interest in high-dose iTBS as a therapeutic tool for psychiatric disorders. We aim to preliminarily investigate the feasibility, safety, and efficacy of high-dose iTBS in children with autism spectrum disorder (ASD).MethodsA randomized controlled pilot trial with a 4-week intervention will be conducted. Forty children with ASD will be randomized into either the intervention or control group. The intervention group will receive 5400-pulse iTBS per day, while the control group will receive sham iTBS. Feasibility will be evaluated through recruitment, intervention adherence, and assessment completion. Safety will be assessed by comparing the rates of drop-outs attributed to adverse events and the rates of serious adverse events The efficacy outcomes include the Autism Behavior Checklist, Social Responsiveness Scale, 2nd Edition, Childhood Autism Rating Scale, Autism Treatment Evaluation Checklist and Repetitive Behavior Scale-Revised. Resting-state electroencephalogram and functional near-infrared spectroscopy will be employed to quantify alterations in functional brain connectivity and cerebral haemodynamics. Salivary levels of oxytocin, growth hormone, insulin-like growth factor 1, and insulin-like growth factor binding protein 3 are measured to reflect the biochemical response to iTBS. These indicators will be assessed at baseline and at the end of the intervention.DiscussionThis trial will evaluate the feasibility, safety, and efficacy of high-dose iTBS treatment in children with ASD. The proposed study will provide pilot data to inform the feasibility and design of larger sample-size trials.Clinical trial registrationhttp://www.chictr.org.cn, identifier ChiCTR2400089757. |
| format | Article |
| id | doaj-art-8778fda5908846bebb722f0b4dafabfb |
| institution | DOAJ |
| issn | 1664-0640 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Psychiatry |
| spelling | doaj-art-8778fda5908846bebb722f0b4dafabfb2025-08-20T02:49:55ZengFrontiers Media S.A.Frontiers in Psychiatry1664-06402025-03-011610.3389/fpsyt.2025.15499821549982Feasibility, safety, and efficacy of high-dose intermittent theta burst stimulation in children with autism spectrum disorder: study protocol for a pilot randomized sham-controlled trialJunzi Long0Junzi Long1Junzi Long2Maoyuan Niu3Maoyuan Niu4Xingxing Liao5Xingxing Liao6Xingxing Liao7Kaiyue Han8Kaiyue Han9Jiarou Chen10Jiarou Chen11Wenlong Su12Xianna Wang13Jianjun Liu14Yan Zhang15Hao Zhang16Hao Zhang17Hao Zhang18Hao Zhang19Hao Zhang20School of Rehabilitation, Capital Medical University, Beijing, ChinaDepartment of Neurorehabilitation, Beijing Boai Hospital, China Rehabilitation Research Center, Beijing, ChinaDivision of Brain Sciences, Changping Laboratory, Beijing, ChinaSchool of Rehabilitation, Capital Medical University, Beijing, ChinaChina Autism Rehabilitation Research Center, Beijing Boai Hospital, China Rehabilitation Research Center, Beijing, ChinaSchool of Rehabilitation, Capital Medical University, Beijing, ChinaDepartment of Neurorehabilitation, Beijing Boai Hospital, China Rehabilitation Research Center, Beijing, ChinaDivision of Brain Sciences, Changping Laboratory, Beijing, ChinaSchool of Rehabilitation, Capital Medical University, Beijing, ChinaDepartment of Neurorehabilitation, Beijing Boai Hospital, China Rehabilitation Research Center, Beijing, ChinaDepartment of Neurorehabilitation, Beijing Boai Hospital, China Rehabilitation Research Center, Beijing, ChinaThe Second Affiliated Hospital and Yuying Children’s Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, ChinaSanBo Brain Hospital, Capital Medical University, Beijing, ChinaChina Autism Rehabilitation Research Center, Beijing Boai Hospital, China Rehabilitation Research Center, Beijing, ChinaChina Autism Rehabilitation Research Center, Beijing Boai Hospital, China Rehabilitation Research Center, Beijing, ChinaChina Autism Rehabilitation Research Center, Beijing Boai Hospital, China Rehabilitation Research Center, Beijing, ChinaSchool of Rehabilitation, Capital Medical University, Beijing, ChinaDepartment of Neurorehabilitation, Beijing Boai Hospital, China Rehabilitation Research Center, Beijing, ChinaDivision of Brain Sciences, Changping Laboratory, Beijing, ChinaChina Autism Rehabilitation Research Center, Beijing Boai Hospital, China Rehabilitation Research Center, Beijing, ChinaThe Second Affiliated Hospital and Yuying Children’s Hospital, Wenzhou Medical University, Wenzhou, Zhejiang, ChinaBackgroundAutism spectrum disorders (ASD) are common neurodevelopmental disorders, mainly caused by disrupted excitation/inhibition balance and synaptic plasticity. Intermittent theta burst stimulation (iTBS) is a variant of excitatory repetitive transcranial magnetic stimulation, inducing long-term potentiation-like plasticity. In recent years, there has been a growing interest in high-dose iTBS as a therapeutic tool for psychiatric disorders. We aim to preliminarily investigate the feasibility, safety, and efficacy of high-dose iTBS in children with autism spectrum disorder (ASD).MethodsA randomized controlled pilot trial with a 4-week intervention will be conducted. Forty children with ASD will be randomized into either the intervention or control group. The intervention group will receive 5400-pulse iTBS per day, while the control group will receive sham iTBS. Feasibility will be evaluated through recruitment, intervention adherence, and assessment completion. Safety will be assessed by comparing the rates of drop-outs attributed to adverse events and the rates of serious adverse events The efficacy outcomes include the Autism Behavior Checklist, Social Responsiveness Scale, 2nd Edition, Childhood Autism Rating Scale, Autism Treatment Evaluation Checklist and Repetitive Behavior Scale-Revised. Resting-state electroencephalogram and functional near-infrared spectroscopy will be employed to quantify alterations in functional brain connectivity and cerebral haemodynamics. Salivary levels of oxytocin, growth hormone, insulin-like growth factor 1, and insulin-like growth factor binding protein 3 are measured to reflect the biochemical response to iTBS. These indicators will be assessed at baseline and at the end of the intervention.DiscussionThis trial will evaluate the feasibility, safety, and efficacy of high-dose iTBS treatment in children with ASD. The proposed study will provide pilot data to inform the feasibility and design of larger sample-size trials.Clinical trial registrationhttp://www.chictr.org.cn, identifier ChiCTR2400089757.https://www.frontiersin.org/articles/10.3389/fpsyt.2025.1549982/fullautism spectrum disordertheta burst stimulationrepetitive transcranial magnetic stimulationfeasibilitysafetyefficacy |
| spellingShingle | Junzi Long Junzi Long Junzi Long Maoyuan Niu Maoyuan Niu Xingxing Liao Xingxing Liao Xingxing Liao Kaiyue Han Kaiyue Han Jiarou Chen Jiarou Chen Wenlong Su Xianna Wang Jianjun Liu Yan Zhang Hao Zhang Hao Zhang Hao Zhang Hao Zhang Hao Zhang Feasibility, safety, and efficacy of high-dose intermittent theta burst stimulation in children with autism spectrum disorder: study protocol for a pilot randomized sham-controlled trial Frontiers in Psychiatry autism spectrum disorder theta burst stimulation repetitive transcranial magnetic stimulation feasibility safety efficacy |
| title | Feasibility, safety, and efficacy of high-dose intermittent theta burst stimulation in children with autism spectrum disorder: study protocol for a pilot randomized sham-controlled trial |
| title_full | Feasibility, safety, and efficacy of high-dose intermittent theta burst stimulation in children with autism spectrum disorder: study protocol for a pilot randomized sham-controlled trial |
| title_fullStr | Feasibility, safety, and efficacy of high-dose intermittent theta burst stimulation in children with autism spectrum disorder: study protocol for a pilot randomized sham-controlled trial |
| title_full_unstemmed | Feasibility, safety, and efficacy of high-dose intermittent theta burst stimulation in children with autism spectrum disorder: study protocol for a pilot randomized sham-controlled trial |
| title_short | Feasibility, safety, and efficacy of high-dose intermittent theta burst stimulation in children with autism spectrum disorder: study protocol for a pilot randomized sham-controlled trial |
| title_sort | feasibility safety and efficacy of high dose intermittent theta burst stimulation in children with autism spectrum disorder study protocol for a pilot randomized sham controlled trial |
| topic | autism spectrum disorder theta burst stimulation repetitive transcranial magnetic stimulation feasibility safety efficacy |
| url | https://www.frontiersin.org/articles/10.3389/fpsyt.2025.1549982/full |
| work_keys_str_mv | AT junzilong feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT junzilong feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT junzilong feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT maoyuanniu feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT maoyuanniu feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT xingxingliao feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT xingxingliao feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT xingxingliao feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT kaiyuehan feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT kaiyuehan feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT jiarouchen feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT jiarouchen feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT wenlongsu feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT xiannawang feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT jianjunliu feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT yanzhang feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT haozhang feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT haozhang feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT haozhang feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT haozhang feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial AT haozhang feasibilitysafetyandefficacyofhighdoseintermittentthetaburststimulationinchildrenwithautismspectrumdisorderstudyprotocolforapilotrandomizedshamcontrolledtrial |