Transcranial Temporal Interference Stimulation for Children With Autism Spectrum Disorders
2026年5月29日 更新者：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.
調査の概要
詳細な説明
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
研究の種類
介入
入学 (推定)
16
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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-
Shanghai Municipality
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Shanghai、Shanghai Municipality、中国、200092
- 募集
- Fei Li
-
コンタクト：
- Fei Li, PHD, MD
- 電話番号：+86-21-25077461
- メール：feili@shsmu.edu.cn
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：デバイスの実現可能性
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
偽コンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Completion of the tTIS intervention protocol
時間枠：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
時間枠：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.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
SRS-2
時間枠：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
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Childhood Autism Rating Scale (CARS)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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Vineland Adaptive Behavior Scales-Third Edition, Vineland-3
時間枠：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
|
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Clinical Global Impression Scale (CGI)
時間枠：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)
時間枠：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
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline in alpha-band EEG power
時間枠：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
時間枠：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 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
時間枠：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.
|
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Change from baseline in inter-trial phase coherence in the theta band
時間枠：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.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月25日
一次修了 (推定)
2026年9月30日
研究の完了 (推定)
2026年10月5日
試験登録日
最初に提出
2026年5月19日
QC基準を満たした最初の提出物
2026年5月29日
最初の投稿 (実際)
2026年6月4日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月4日
QC基準を満たした最後の更新が送信されました
2026年5月29日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- XHEC-C-2026-109-1
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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