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Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders

perjantai 29. toukokuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

16

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Kiina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kiina, 200092
        • Rekrytointi
        • Fei Li
        • Ottaa yhteyttä:

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Lapsi

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Laitteen toteutettavuus
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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
Laite: 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.
Huijausvertailija: 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
Laite: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Completion of the tTIS intervention protocol
Aikaikkuna: 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
Aikaikkuna: 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.

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
SRS-2
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Change from baseline in alpha-band EEG power
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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.

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • XHEC-C-2026-109-1

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

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.

Lääke- ja laitetiedot, tutkimusasiakirjat

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