Evaluating the Efficacy of Transcranial Pulse Stimulation (TPS) on Individuals with Autism Spectrum Disorder (ASD)- a Double-blinded, Randomized, Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Autism severity
研究概览
简要总结
The aim of this study is to evaluate the efficacy and tolerability of TPS on young adolescents with ASD. Methods: This is a two-armed, randomized, double-blinded, sham-controlled trial. Sampling: A total number of 36 subjects, aged between 12 to 17, diagnosed with ASD, will be recruited. Individuals with a Childhood of Autism Rating Scale (CARS) score ≤ 30 (i.e., no ASD) will be excluded. Recruitment: Subjects will be recruited from the community. Block randomization will be performed to allocate subjects to either the verum TPS group or the sham TPS group on a 1: 1 ratio. Interventionists and subjects will be blinded in the randomization process. Intervention: Intervention: Six 30-minures TPS sessions will be delivered to the verum TPS group (800 pulse in each session, total: 4800 pulse) in consecutive two weeks. The treatment brain region is targeted at the right temporoparietal junction (rTPJ). The sham- controlled group will be given 6 sham TPS sessions. Data collection: All participants are required to undertake pre-and-post fMRI and resting-MRI before the TPS procedures. Outcomes: Primary outcome of this study is CARS, and secondary outcomes include Autism Spectrum Quotient (AQ), Australian scale for Asperger's syndrome (ASAS), Social Responsive Scale (SRS), Faux Pas Recognition Test (FPRT), Stroop test, working memory, Clinical global impression - severity and improvement scale (CGI-S and CGI -I) and neuroimaging. All outcome measures will be assessed at baseline, two weeks immediately after intervention and at 1-month and 3-months follow-up.
详细描述
Primary objective:
- Participants in the verum TPS group will have a significant reduction in CARS score at posttreatment compared with the sham TPS group.
Secondary objectives: 2. Participants in the verum TPS group will have significant improvement in Autism Spectrum Quotient (AQ), compared with the sham TPS group. 3. Participants in the verum TPS group will have significant improvement in the Social Responsiveness Scale (SRS), compared with the sham TPS group. 4. Participants in the verum TPS group will have significant improvement in Faux Pas Recognition Test, compared with the sham TPS group. 5. Participants in the verum TPS group will have significant improvement in Stroop test, compared with the sham TPS group. 6. Participants in the verum TPS group will have significant improvement in Clinical global impression - severity and improvement scale (CGI-S and CGI -I) compared with the sham TPS group. 7. Participants in the verum TPS group will have significant brain function connectivity at posttreatment fMRI and resting-state MRI compared to the sham TPS group.
Sample size Based on an RCT with similar design, the estimated effect size of rTMS is 0.5. By adapting an ANOVA 2x2 repeated measures with 95% significance and a power of 0.8, a sample size of 36 will be required in total (18 subjects per group).
Research plan and Methodology Methods Trial Design: In this study, the investigators will use a double-blind randomized controlled trial design with two-armed repeated measures. The trial design complies with the Consolidated Standards of Reporting Trials (CONSORT) statement. In this two-armed design, investigators will use TPS as an intervention group and a waitlist control group. A sham-control group is appropriate for comparing the effect of the TPS on the intervention group to that of those not receiving the TPS treatment at the same timepoints Both groups will be measured at baseline (T1), immediately after the intervention (T2), at the 1-month (T3) and 3-month follow-up (T4). Based on the previous studies, a 3-month follow-up is sufficient to assess the long-term sustainability of the TPS 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
- Double (Participant, Investigator)
盲法说明
Double-blind. Participants and interventionists will be blinded to the random allocation to either the verum TPS group or the sham TPS group.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 -17 years of age
- •Chinese ethnicity
- •Diagnosis of Autistic Spectrum Disorder that meets the criteria of the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- •No change in their management including medications or non-pharmacological intervention
- •Currently taking prescribed psychotropic medications for ≥ 3 months
排除标准
- •A DSM-5 diagnosis other than ASD
- •Concomitant major medical or neurological conditions, such as significant global developmental delay, skull defect, abnormal mass or tumor, or epilepsy
- •A CARS score ≤ 30 (i.e., no ASD)
结局指标
主要结局
Autism severity
时间窗: Changes in CARS scores from baseline at 3 months
The Childhood Autism Rating Scale (CARS) is a 15-item behavioral rating scale developed to identify autism and examine its severity. Total scores range from a low of 15 to a high of 60; scores below 30 indicate that the individual is in the non-autistic range, scores between 30 and 36.5 indicate mild to moderate autism, and scores from 37 to 60 indicate severe autism.
次要结局
- Asperger's Syndrome(Changes in ASAS from baseline at 3 months)
- Executive Function(Changes in Stroop test from baseline at 3 months)
- Social deficits(Changes in SRS from baseline at 3 months)
- Clinical Global Impression(Changes in WMTB from baseline at 3 months)
- Theory of Mind and Social Cognition(Changes in FPRT from baseline at 3 months)
- Working memory(Changes in WMTB from baseline at 3 months)
- Neuroimaging(MRI will be assessed at baseline at immediately and 2 weeks after post-stimulation)
- Autistic traits(Changes in AQ scores from baseline at 3 months)