Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders
29. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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
Studientyp
Interventionell
Einschreibung (Geschätzt)
16
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, China, 200092
- Rekrutierung
- Fei Li
-
Kontakt:
- Fei Li, PHD, MD
- Telefonnummer: +86-21-25077461
- E-Mail: feili@shsmu.edu.cn
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Machbarkeit des Geräts
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
|
|
Schein-Komparator: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Completion of the tTIS intervention protocol
Zeitfenster: 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
Zeitfenster: 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.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
SRS-2
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change from baseline in alpha-band EEG power
Zeitfenster: 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
Zeitfenster: 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.
|
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Change from baseline in inter-trial phase coherence in the alpha band
Zeitfenster: 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.
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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
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
25. Mai 2026
Primärer Abschluss (Geschätzt)
30. September 2026
Studienabschluss (Geschätzt)
5. Oktober 2026
Studienanmeldedaten
Zuerst eingereicht
19. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
29. Mai 2026
Zuerst gepostet (Tatsächlich)
4. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
4. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
29. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- XHEC-C-2026-109-1
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
NEIN
Beschreibung des IPD-Plans
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.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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