Cumulative and Booster Effects of Multisession Prefrontal tDCS on Cognitive and Social Impairments in Adolescents With Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2)
研究概览
简要总结
Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by disturbances in communication, poor social skills, and aberrant behavior. To date, ASD has no known cure, and the disorder remains a highly disabling condition. Recently, transcranial direct-current stimulation (tDCS), a non-invasive brain stimulation technique, has shown great promise as a potentially effective and cost-effective tool for reducing the core symptoms in patients with autism, such as anxiety, aggression, impulsivity, and inattention. Although the preliminary findings in patients with ASD are encouraging, it remains to be determined whether this experimental data can translate into benefits in real life. Further studies are needed to determine the factors that can lengthen the therapeutic effects or cognitive benefits of tDCS, and to determine possible risk factors associated with relapse in patients with ASD. Booster sessions of tDCS is an important component of treatment planning and prognosis and may promote better outcomes to control for resurgence of symptoms. This study has three aims. First, the investigators aim to evaluate the therapeutic effects of tDCS on improving cognitive function in patients with ASD. Second, the investigators aim to better understand the neural mechanisms underlying the neuro-enhancing effects of tDCS in patients with ASD. Third, the investigators aim to assess the effectiveness of booster treatment cycles of tDCS for enhancing cognitive and social functions in individuals with ASD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who are confirmed by a clinical psychologist based on the Diagnostic and Statistical Manual of Mental Disorders-5th Ed (DSM-V) criteria of Autism spectrum disorder and structured interview with their parents or primary caregivers on their developmental history using the Autism Diagnostic Interview-Revised (ADI-R).
排除标准
- •Individuals without a confirmed diagnosis from the clinical psychologist, with a history of other neurological and psychiatric disorders and head trauma, or on psychiatric medication will be excluded from the study.
研究组 & 干预措施
Active-tDCS vs Sham-tDCS
During the active- and sham-tDCS conditions, the participants will receive current with ramp up and ramp down mode for 10 seconds, eliciting a tingling sensation on the scalp that fades over seconds. Following that, the tasks will be initiated five minutes subsequent to the stimulation mode and terminated prior to its end for active-tDCS condition. Whereas, the sham condition with the same placement and intensity will only receive 30s initial stimulation and then discontinue. Throughout the active / sham-tDCS condition, participants are required to sit still and focus their attention on a "+" displayed on a computer monitor during the five-minute rest. After that, they will undergo active-tDCS (1mA, 20 min) to the left DLPFC or sham stimulation over 10 sessions in 2 weeks, while performing the executive function training tasks.
干预措施: Active-tDCS (Device)
Active-tDCS vs Sham-tDCS
During the active- and sham-tDCS conditions, the participants will receive current with ramp up and ramp down mode for 10 seconds, eliciting a tingling sensation on the scalp that fades over seconds. Following that, the tasks will be initiated five minutes subsequent to the stimulation mode and terminated prior to its end for active-tDCS condition. Whereas, the sham condition with the same placement and intensity will only receive 30s initial stimulation and then discontinue. Throughout the active / sham-tDCS condition, participants are required to sit still and focus their attention on a "+" displayed on a computer monitor during the five-minute rest. After that, they will undergo active-tDCS (1mA, 20 min) to the left DLPFC or sham stimulation over 10 sessions in 2 weeks, while performing the executive function training tasks.
干预措施: Sham-tDCS (Device)
Crossover trial
Participants in the sham-tDCS group will receive 10-day active tDCS and assessments will be performed before and after the 10-tDCS session.
干预措施: Active-tDCS (Device)
Booster effect
All tDCS responders (>10% reduction in SRS scores) will enrol on a 6 months follow-up phase in which they will be randomized to receive either bimonthly 20-minute booster tDCS sessions, or bimonthly 20-minute booster sham tDCS sessions for 3 months, followed by monthly 20-minute booster tDCS, monthly 20-minute booster sham tDCS, for another 3 months, with a maximum of 9 (sham) tDCS booster sessions.
干预措施: Active-tDCS (Device)
Booster effect
All tDCS responders (>10% reduction in SRS scores) will enrol on a 6 months follow-up phase in which they will be randomized to receive either bimonthly 20-minute booster tDCS sessions, or bimonthly 20-minute booster sham tDCS sessions for 3 months, followed by monthly 20-minute booster tDCS, monthly 20-minute booster sham tDCS, for another 3 months, with a maximum of 9 (sham) tDCS booster sessions.
干预措施: Sham-tDCS (Device)
结局指标
主要结局
Change in social responsiveness - Social Responsiveness Scale-2nd edition (SRS-2)
时间窗: Phase 1 (RCT): Week 0, week 2, week 4, and week 6 of the study (4 time points); Phase 2 (crossover): Week 0 and week 2 (2 time points); Phase 3 (follow-up): Week 6, 10, 14, 18, 22, 26 (6 time points)
SRS-2 is a sensitive measure of social functioning in children that detects even subtle symptoms that are highly related to ASD. It uses a four-point scale and focuses on different aspects of socialization. The total score reflects the clinical effectiveness of tDCS, and higher scores indicate greater symptom severity. It has been shown that SRS-2 is sensitive to detect changes in social communication improvement related to improved cognitive functioning after treatment. SRS-2 assessments will be conducted 1 day before and 1 day after tDCS treatment.
次要结局
- Change in neuropsychological measures - CANTAB® cognitive tests(Phase 1 (RCT): Week 0, week 2, week 4, and week 6 of the study (4 time points); Phase 2 (crossover): Week 0 and week 2 (2 time points); Phase 3 (follow-up): Week 6, 10, 14, 18, 22, 26 (6 time points))
- Clinical response in tDCS outcome(Phase 1 (RCT): Week 0, week 2, week 4, and week 6 of the study (4 time points); Phase 2 (crossover): Week 0 and week 2 (2 time points))
研究者
Dr Yvonne Han
Associate Professor
The Hong Kong Polytechnic University