Effects of cTBS on Sensory Integration in Children With Autism Spectrum Disorder: A Randomized, Sham-Controlled Study Integrating Genetic Markers, MRI, fNIRS, and Temporal Binding Tasks
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Change in Temporal Binding Window (TBW) Width Measured Using the Sound-Induced Flash Illusion (SIFI) Task
研究概览
简要总结
The goal of this clinical trial is to find out if brain stimulation can help improve sensory integration in children ages 6 to 12 with autism spectrum disorder (ASD). The main questions it aims to answer are:
Does brain stimulation using continuous theta-burst stimulation (cTBS) on bilateral dorsolateral prefrontal cortex (DLPFC) improve how children process sights and sounds together? Can brain functioning, structure, and genetics help predict who responds best to this treatment?
Researchers will compare the results of the randomly assigned active brain stimulation to sham (inactive) stimulation groups to see if the treatment works.
Participants will:
Receive 10 sessions of either active or sham cTBS over 2 weeks Complete a sensory task involving flashes and beeps before and after stimulation Take part in brain scans, namely magnetic resonance imaging (MRI) and functional near-infrared spectroscopy (fNIRS), and provide a saliva sample for genetic testing
详细描述
This study explores how noninvasive brain stimulation may support children with Autism Spectrum Disorder (ASD) by improving how their brains process and combine sounds and images. It also investigates whether changes in brain function, brain structure, and specific genes can help predict how well a child might respond to this type of stimulation. The study is focused on a core challenge in ASD: differences in how children experience sensory input-especially how their brains process what they see and hear together.
The central concept in this research is something called the Temporal Binding Window (TBW). TBW refers to the brief time window in which the brain naturally fuses sensory information from different senses-like sight and sound-into a single event. For most people, this window is quite narrow: sounds and images that are even slightly out of sync are perceived as separate. But in many children with ASD, this window is wider. That means they may confuse the order or timing of sensory inputs, which can affect communication, behavior, and learning.
To address this, the study uses a method called transcranial magnetic stimulation (TMS). This technique delivers brief, painless pulses of magnetic energy to the surface of the brain using a special coil held against the scalp. The type of TMS used here is called continuous theta burst stimulation (cTBS), which delivers rapid bursts of magnetic pulses designed to gently decrease the excitability of targeted brain areas. In this study, cTBS is used to modulate activity in a region called the dorsolateral prefrontal cortex (DLPFC), which is important for regulating attention, working memory, and sensory control.
A total of 40 children between the ages of 6 and 12 will take part. All participants must have a formal diagnosis of ASD, confirmed using a structured caregiver interview known as the Autism Diagnostic Interview - Revised (ADI-R). They must also demonstrate average or above-average cognitive ability, based on a two-subscale IQ measure from the Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V). This ensures that all children can understand the tasks and safely undergo the procedures.
Participants are randomly assigned to one of two groups: an active TMS group or a sham TMS group. In the sham group, the same equipment is used, but no actual magnetic stimulation reaches the brain. This allows researchers to compare outcomes while keeping the children, their families, and the staff unaware of group assignments.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, care providers, investigators, and outcome assessors are all blinded to group assignment (active vs. sham TMS). The sham condition mimics the sound and sensation of stimulation without delivering active magnetic pulses, using an identical setup. Randomization and group codes are maintained by an independent administrator and not revealed until after final data analysis. Blinding is used to reduce bias in behavioral, neurophysiological, and questionnaire-based outcomes.
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 6-12 years at the time of enrollment.
- •Clinical diagnosis of Autism Spectrum Disorder (ASD) confirmed using the Autism Diagnostic Interview-Revised (ADI-R).
- •Intelligence quotient (IQ) ≥ 70 as measured by the General Ability Index (GAI) from the Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V).
- •Ability to understand and follow simple instructions for behavioral tasks and stimulation procedures.
- •Stable medication regimen (if any) for at least 4 weeks before the start of the study.
- •Written informed consent from a parent or legal guardian, and assent from the child when appropriate.
排除标准
- •History of epilepsy, seizures, or abnormal EEG suggestive of seizure risk.
- •Presence of metal implants, devices, or foreign bodies in or near the head (except dental fillings) that are contraindicated for TMS or MRI.
- •Serious neurological disorders other than ASD (e.g., cerebral palsy, brain injury, neurodegenerative disease).
- •Severe psychiatric disorders requiring hospitalization or urgent intervention.
- •Current or past history of significant head trauma with loss of consciousness > 5 minutes.
- •Uncorrected hearing or vision problems that could interfere with task performance.
- •Inability to tolerate sitting still for 15-20 minutes.
- •Participation in another interventional clinical trial within the past 3 months.
结局指标
主要结局
Change in Temporal Binding Window (TBW) Width Measured Using the Sound-Induced Flash Illusion (SIFI) Task
时间窗: Baseline and up to 7 days after the final TMS session.
The TBW reflects the time interval within which auditory and visual stimuli are integrated as a single percept. It is assessed by computing the proportion of illusion-consistent responses across varying stimulus onset asynchronies in the SIFI task. A reduction in TBW width, measured in milliseconds (ms) following stimulation indicates improved multisensory temporal precision.
次要结局
- Change in Sensory Processing Profile (Short Sensory Profile, SSP)(Baseline and up to 7 days after the final TMS session.)
- Change in Autism Symptom Severity (Autism Treatment Evaluation Checklist, ATEC)(Baseline and up to 7 days after the final TMS session.)
- Change in Resting-State Prefrontal Activity - Mean Oxygenation (fNIRS)(Baseline and up to 7 days after the final TMS session.)
- Change in Resting-State Prefrontal Activity - Functional Connectivity (fNIRS)(Baseline and up to 7 days after the final TMS session.)