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Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders

29. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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

Typ studie

Intervenční

Zápis (Odhadovaný)

16

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Čína
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Čína, 200092
        • Nábor
        • Fei Li
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Proveditelnost zařízení
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Dvojnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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
Přístroj: transcranial Temporal Interference Stimulation
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.
Falešný srovnávač: 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
Přístroj: transcranial Temporal Interference Stimulation
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Completion of the tTIS intervention protocol
Časové okno: 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.
During the 5-day intervention
Number of participants with adverse events
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
SRS-2
Časové okno: 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)
Časové okno: 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
Social Responsiveness Scale, Second Edition (SRS-2)
Časové okno: 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
Časové okno: 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.
Baseline, 4 weeks after completion of 5-day intervention
Peabody Picture Vocabulory Test, PPVT
Časové okno: 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
Časové okno: 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
Vineland Adaptive Behavior Scales-Third Edition, Vineland-3
Časové okno: 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.
Baseline, 4 weeks after completion of 5-day intervention
Clinical Global Impression Scale (CGI)
Časové okno: 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.
after completion of 5-day intervention, four weeks after completion of 5-day intervention
Multilingual Assessment Instrument for Narratives (MAIN)
Časové okno: Baseline, 4 weeks after completion of 5-day intervention
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.
Baseline, 4 weeks after completion of 5-day intervention

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline in alpha-band EEG power
Časové okno: 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.
Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.
Change from baseline in theta-band EEG power
Časové okno: 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.
Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.
Change from baseline in inter-trial phase coherence in the alpha band
Časové okno: Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.
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.
Baseline, immediately after completion of the 5-day intervention, and 4 weeks after completion of the 5-day intervention.
Change from baseline in inter-trial phase coherence in the theta band
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

25. května 2026

Primární dokončení (Odhadovaný)

30. září 2026

Dokončení studie (Odhadovaný)

5. října 2026

Termíny zápisu do studia

První předloženo

19. května 2026

První předloženo, které splnilo kritéria kontroly kvality

29. května 2026

První zveřejněno (Aktuální)

4. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

4. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • XHEC-C-2026-109-1

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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