Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders
29 de maio de 2026 atualizado por: Fei Li, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Individualized Targeted Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorder: A Single-Blinded, Randomized, Controlled Exploratory Trial
The goal of this single-blinded, randomized controlled trial is to assess the safety, tolerability, and feasibility of tTIS for children with ASD. The main question it aims to answer is:
- Is tTIS safe, tolerable, and feasible for use for children with autism spectrum disorder?
Researchers will compare tTIS group with control group to explore the safety and feasibility of the transcranial electrical stimulation for children with autism.
Participants will:
- tTIS group: undergo 5 days of temporal tTIS.
- Sham group: undergo 5 days of temporal tTIS without low-frequency envelope.
From baseline to 4 weeks after intervention completion, subjects will be followed up regarding clinical symptoms and adverse events:
- Primary Outcome Measures: Safety and feasibility of tTIS, assessed by adverse events, treatment completion rate, adherence to the stimulation protocol and tolerability.
- Secondary/Exploratory Outcome Measures: Changes in SRS-2 total scores and other clinical measures related to language, adaptive functioning, and cognition.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
This research is a 5-week single-blinded, randomized controlled trial, planning to enroll 16 ASD children aged 4-10 with a full-scale intelligence quotient (FSIQ) of 50 or above. Children who satisfy all inclusion criteria without meeting any exclusion criteria, may be enrolled after their legal guardians provided the written informed consent.
Eligible subjects will be randomly divided into two groups: tTIS group and sham group. The tTIS group will undergo 5 days of temporal TI stimulation (1.5mA, 2040/2000Hz, 20min/session, 6 sessions/day); the control group will undergo 5 days of temporal TI stimulation (1.5mA, 2000/2000Hz, 20min/session, 6 sessions/day, without 40Hz envelope compared to tTIS group)
At baseline, subjects will undergo physical measurements, demographic and medical history collection, intelligence test and symptom clinical scale assessments, and resting-state EEG collection. From the start of intervention until 4 weeks after completion, subjects will be followed up regarding clinical symptoms, neuroimaging, and adverse events.
Primary Outcome Measures:
- Safety and feasibility of tTIS, assessed by adverse events, treatment completion rate, adherence to the stimulation protocol and tolerability.
Secondary outcomes:
- Change in Social Responsiveness Scale, Second Edition (SRS-2) total score from baseline to immediately after completion of the 5-day intervention.
- Change in SRS-2 total score from baseline to 4 weeks after completion of the 5-day intervention.
- Changes in other clinical measures from baseline to 4 weeks after completion of the 5-day intervention, including the Chinese Communicative Development Inventory (CCDI), Childhood Autism Rating Scale (CARS), Peabody Picture Vocabulary Test (PPVT), selected subtests of A Developmental Neuropsychological Assessment, Second Edition (NEPSY-II; Narrative Memory, Memory for Faces, Theory of Mind, Word Generation, and Affect Recognition), and Clinical Global Impression (CGI) scale scores.
Exploratory Outcomes:
- resting-state and task-state EEG neuroimaging characteristics before intervention, immediately after the 5-day intervention, and 4 weeks after completion of the 5-day intervention
Tipo de estudo
Intervencional
Inscrição (Estimado)
16
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200092
- Recrutamento
- Fei Li
-
Contato:
- Fei Li, PHD, MD
- Número de telefone: +86-21-25077461
- E-mail: feili@shsmu.edu.cn
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Children aged 4-10 years
- Meeting the diagnostic criteria for ASD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and confirmed by the Autism Diagnostic Observation Schedule (ADOS) and/or the Autism Diagnostic Interview-Revised (ADI-R)
- Full Scale Intelligence Quotient (FSIQ) ≥50
- Signed informed consent form
Exclusion Criteria:
- Individuals with metal implants in the body
- Individuals with neurological disorders such as epilepsy
- Those requiring surgical treatment due to structural abnormalities indicated by brain MRI examination
- Those diagnosed with genetic or chromosomal abnormalities
- Individuals with mental illness (such as early-onset schizophrenia)
- Those with severe cardiac disease
- Individuals with increased intracranial pressure
- Those currently participating in other clinical trials
- Those who received new intervention protocols within 4 weeks prior to enrollment.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Viabilidade do dispositivo
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Intervention group (tTIS)
Receive tTIS targeting the anterior middle temporal gyrus, with stimulation frequency of 2040/2000HZ, using battery power supply: voltage 12V, current set at 1.5mA, 6 times/day, 20min/session with 20min intervals between sessions, lasting for 5 days
|
Receive tTIS targeting the anterior middle temporal gyrus with stimulation frequency of 2040/2000HZ, using battery power supply: voltage 12V, current set at 1.5mA, 6 times/day, 20min/session with 20min intervals between sessions, lasting for 5 days.
|
|
Comparador Falso: Control group
Receive tTIS targeting the anterior middle temporal gyrus, with stimulation frequency of 2000/2000HZ(without 40Hz envelope compared to tTIS group), using battery power supply: voltage 12V, current set at 1.5mA, 6 times/day, 20min/session with 20min intervals between sessions, lasting for 5 days
|
Receive tTIS targeting the anterior middle temporal gyrus with stimulation frequency of 2040/2000HZ, using battery power supply: voltage 12V, current set at 1.5mA, 6 times/day, 20min/session with 20min intervals between sessions, lasting for 5 days.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Completion of the tTIS intervention protocol
Prazo: During the 5-day intervention
|
The proportion of participants who complete all scheduled tTIS sessions according to the predefined stimulation protocol during the 5-day intervention.
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During the 5-day intervention
|
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Number of participants with adverse events
Prazo: From the start of the intervention to 4 weeks after completion of the 5-day intervention.
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The number and proportion of participants who experience adverse events during the study period.
|
From the start of the intervention to 4 weeks after completion of the 5-day intervention.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
SRS-2
Prazo: Baseline, after completion of 5-day intervention
|
Change from baseline in SRS-2 score immediately after the 5-day intervention.
The SRS-2 is primarily used to assess symptoms associated with ASD.
Compared to other autism assessment tools, the SRS-2 stands out for its focus on quantifying the severity of social impairment, with higher scores indicating more autism symptoms and greater social disability.
|
Baseline, after completion of 5-day intervention
|
|
Childhood Autism Rating Scale (CARS)
Prazo: Baseline, 4 weeks after completion of 5-day intervention
|
Change in CARS score from baseline to 4 weeks after the 5-day intervention.
CARS is a behavior rating scale used to assess the presence and severity of the symptoms associated autism spectrum disorder.
The scores of the CARS rate from 15 to 60, and higher scores indicate more severe symptoms.
The changes in the CAR scores from baseline to 3 months after the treatment will be analyzed to asses the impact often intervention on participants with ASD.
|
Baseline, 4 weeks after completion of 5-day intervention
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|
Social Responsiveness Scale, Second Edition (SRS-2)
Prazo: Baseline, 4 weeks after completion of 5-day intervention
|
Change in SRS-2 score from baseline to 4 weeks after completion of the 5-day intervention.The SRS-2 is primarily used to assess symptoms associated with ASD.
Compared to other autism assessment tools, the SRS-2 stands out for its focus on quantifying the severity of social impairment, with higher scores indicating more autism symptoms and greater social disability.
|
Baseline, 4 weeks after completion of 5-day intervention
|
|
Chinese Communicative Development Inventory, CCDI
Prazo: Baseline, 4 weeks after completion of 5-day intervention
|
Change in CCDI score from baseline to 4 weeks after the 5-day intervention.Chinese Communicative Development Inventory(CCDl) is a questionnaire used to measures the language abilities.
Higher scores suggest better language level.
The changes in the CCDl between baseline and 3 month after treatment will be analyzed.
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Baseline, 4 weeks after completion of 5-day intervention
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Peabody Picture Vocabulory Test, PPVT
Prazo: Baseline, 4 weeks after completion of 5-day intervention
|
Change in PPVT score from baseline to 4 weeks after the 5-day intervention.
PPVT as a tool for measuring children's language receptive ability and language comprehension ability.
|
Baseline, 4 weeks after completion of 5-day intervention
|
|
Neuropsychological Assessment for Child, NEPSY-II
Prazo: Baseline, 4 weeks after completion of 5-day intervention
|
Change in NEPSY-II score from baseline to 4 weeks after the 5-day intervention.
NEPSY-II is a comprehensive neuropsychological measurement tool used for assessing neuro-cognitive functions in children aged 3-16 years.
This study primarily evaluates the following aspects: narrative memory assessment, facial memory assessment, theory of mind, word generation, affection recognition.
|
Baseline, 4 weeks after completion of 5-day intervention
|
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Vineland Adaptive Behavior Scales-Third Edition, Vineland-3
Prazo: Baseline, 4 weeks after completion of 5-day intervention
|
Change in VABS-3 score from baseline to 4 weeks after the 5-day intervention.
The VABS-3 is used to measure adaptive functioning across domains such as communication,daily living skills, socialization, and motor skills.
Changes in VABs scores from baseline to 3 months post-treatment will be analyzed to assess the intervention's impact on adaptive behaviors in children with ASD.
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Baseline, 4 weeks after completion of 5-day intervention
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Clinical Global Impression Scale (CGI)
Prazo: after completion of 5-day intervention, four weeks after completion of 5-day intervention
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The Clinical Global Impressions (CGI) scale is used to assess both the severity of illness and the global improvement of participants undergoing intervention.
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after completion of 5-day intervention, four weeks after completion of 5-day intervention
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Multilingual Assessment Instrument for Narratives (MAIN)
Prazo: Baseline, 4 weeks after completion of 5-day intervention
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Change in MAIN score from baseline to 4 weeks after the 5-day intervention.
MAIN assess narrative comprehension and production skills of children who exhibited a certain level of expressive ability (at least can use flexible phrases).
In this test, children tell or retell the stories and answer some questions, with assessors evaluating performance.
Higher scores suggest better language level.
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Baseline, 4 weeks after completion of 5-day intervention
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change from baseline in alpha-band EEG power
Prazo: Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.
|
Change in alpha-band EEG power from baseline to immediately after completion of the 5-day intervention and to 4 weeks after completion of the 5-day intervention.
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Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.
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Change from baseline in theta-band EEG power
Prazo: Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.
|
Change in theta-band EEG power from baseline to immediately after completion of the 5-day intervention and to 4 weeks after completion of the 5-day intervention.
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Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.
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Change from baseline in inter-trial phase coherence in the alpha band
Prazo: Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.
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Change in alpha-band inter-trial phase coherence from baseline to immediately after completion of the 5-day intervention and to 4 weeks after completion of the 5-day intervention.
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Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.
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Change from baseline in inter-trial phase coherence in the theta band
Prazo: Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.
|
Change in theta-band inter-trial phase coherence from baseline to immediately after completion of the 5-day intervention and to 4 weeks after completion of the 5-day intervention.
|
Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
25 de maio de 2026
Conclusão Primária (Estimado)
30 de setembro de 2026
Conclusão do estudo (Estimado)
5 de outubro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
19 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de maio de 2026
Primeira postagem (Real)
4 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- XHEC-C-2026-109-1
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
The study Protocol, statistical Analysis plan, informed Consent Form, and other relevant documents will be available under reasonable and ethically approved request to the corresponding authors.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .