Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders
29 de mayo de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
16
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200092
- Reclutamiento
- Fei Li
-
Contacto:
- Fei Li, PHD, MD
- Número de teléfono: +86-21-25077461
- Correo electrónico: feili@shsmu.edu.cn
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Viabilidad del dispositivo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Completion of the tTIS intervention protocol
Periodo de tiempo: 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
Periodo de tiempo: From the start of the intervention to 4 weeks after completion of the 5-day intervention.
|
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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
SRS-2
Periodo de tiempo: 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)
Periodo de tiempo: 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.
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Baseline, 4 weeks after completion of 5-day intervention
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|
Social Responsiveness Scale, Second Edition (SRS-2)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Baseline, 4 weeks after completion of 5-day intervention
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Vineland Adaptive Behavior Scales-Third Edition, Vineland-3
Periodo de tiempo: 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)
Periodo de tiempo: after completion of 5-day intervention, four weeks after completion of 5-day intervention
|
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)
Periodo de tiempo: 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
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline in alpha-band EEG power
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
25 de mayo de 2026
Finalización primaria (Estimado)
30 de septiembre de 2026
Finalización del estudio (Estimado)
5 de octubre de 2026
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de mayo de 2026
Publicado por primera vez (Actual)
4 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- XHEC-C-2026-109-1
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .