Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders
29 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
16
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200092
- Reclutamento
- Fei Li
-
Contatto:
- Fei Li, PHD, MD
- Numero di telefono: +86-21-25077461
- Email: feili@shsmu.edu.cn
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Bambino
Accetta volontari sani
No
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Fattibilità del dispositivo
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore fittizio: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Completion of the tTIS intervention protocol
Lasso di tempo: 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
|
|
Number of participants with adverse events
Lasso di tempo: 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.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
SRS-2
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change from baseline in alpha-band EEG power
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
25 maggio 2026
Completamento primario (Stimato)
30 settembre 2026
Completamento dello studio (Stimato)
5 ottobre 2026
Date di iscrizione allo studio
Primo inviato
19 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
29 maggio 2026
Primo Inserito (Effettivo)
4 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
4 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
29 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- XHEC-C-2026-109-1
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .