Temporal Pole Transcranial Alternating Current Stimulation for Children With Autism Spectrum Disorder: A Randomized Controlled Open-Label Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Social Responsiveness Scale, SRS-2
研究概览
简要总结
The goal of this open-label randomized controlledl trial is to explore the safety and efficacy of conventional transcranial alternating current stimulation (tACS) and transcranial temporal interference stimulation (tTIS) targeting the temporal pole in children with autism spectrum disorder (ASD) in China. The main questions it aims to answer are:
*Can tACS and tTIS safely and effectively improve clinical symptoms in children with autism?
Researchers will compare the tACS group and tTIS group with control group to explore the safety, feasibility and efficacy of the transcranial electrical stimulation in children with autism.
Participants will:
- tACS group: undergo 5 days of temporal pole tACS
- tTIS group:undergo 5 days of temporal pole tTIS
- Control group: receive routine rehabilitation training during the study period.
From baseline to 4 weeks after intervention completion, subjects will be followed up regarding clinical symptoms and adverse reactions:
- Safety Outcome Measures: adverse events
- Primary Efficacy Outcome Measures: Social Responsiveness Scale (SRS-2) total scores
- Other clinical outcome measures related language, adapative function and cognition
详细描述
This research is a 5-week prospective, open-label, randomized controlled trial, planning to enroll 36 autistic 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 three groups: tACS group, tTIS group and control group. The tACS group will undergo 5 days of temporal pole tACS stimulation (1.5mA, 40Hz, 20min/session, 6 sessions/day); the tTIS group will undergo 5 days of temporal pole TI stimulation（1.5mA, 2040/2000Hz, 20min/session, 6 sessions/day）; the control group will receive routine rehabilitation training during the study period, including various rehabilitation services provided by the community.
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 reactions.
The safety outcome: adverse events and their rate. The primary efficacy outcome is the change in Social Responsiveness Scale (SRS-2) scores 4 weeks after intervention completion compared to pre-intervention.
Secondary outcomes include changes in SRS-2 scores immediately after the 5-day intervention compared to pre-intervention; and changes in Chinese Communicative Development Inventory (CCDI), Childhood Autism Rating Scale (CARS), Peabody Picture Vocabulary Test (PPVT), Developmental Neuropsychological Assessment (NEPSY-II, including narrative memory, facial memory, theory of mind, vocabulary generation) four items, and Clinical Global Impression (CGI) scale scores 4 weeks after the 5-day intervention compared to pre-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of Clinical Scale Assessors
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •Diagnosis 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
排除标准
- •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 mood disorders, etc.)
- •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.
研究组 & 干预措施
Intervention group(tACS)
Receive tACS stimulation targeting the temporal pole, with stimulation frequency of 40Hz, using adapter power supply: voltage 9V, current set at 1.5mA, 6 times/day, 20min/session with 20min intervals between sessions, lasting for 5 days
干预措施: Transcranial Alternating Current Stimulation (Device)
Control group
Receive routine rehabilitation training during the study period
Intervention group(tTIS)
Receive tTIS targeting the temporal pole, 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
干预措施: transcranial Temporal Interference Stimulation (Device)
结局指标
主要结局
Social Responsiveness Scale, SRS-2
时间窗: Baseline, 4 weeks after completion of 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.
次要结局
- Childhood Autism Rating Scale (CARS)(Baseline, 4 weeks after completion of 5-day intervention)
- Neuropsychological Assessment for Child, NEPSY-II(Baseline, 4 weeks after completion of 5-day intervention)
- SRS-2(Baseline, after completion of 5-day intervention)
- Chinese Communicative Development Inventory, CCDI(Baseline, 4 weeks after completion of 5-day intervention)
- Peabody Picture Vocabulory Test, PPVT(Baseline, 4 weeks after completion of 5-day intervention)
- Vineland Adaptive Behavior Scales-Third Edition, Vineland-3(Baseline, 4 weeks after completion of 5-day intervention)
- Clinical Global Impression Scale (CGI)(after completion of 5-day intervention, four weeks after completion of 5-day intervention)
研究者
Fei Li
Chief Physician, Doctoral Supervisor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine