NCT07225322尚未招募1 期
Low Intensity Focused Ultrasound in Autism Spectrum Disorder
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Social Responsiveness Scale, Second Edition (SRS-2)
研究概览
简要总结
This study investigates the safety and potential efficacy of personalized, image-guided low intensity focused ultrasound (LIFU) targeting the thalamus in individuals with Autism Spectrum Disorder (ASD). The study evaluates behavioral, neuroimaging, and electrophysiological outcomes following LIFU stimulation using a non-invasive device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13-25
- •Diagnosis of ASD (DSM-5)
- •Full Scale IQ > 70
- •Verbal communication
- •Stable medication for ≥1 month
- •Ability to consent or assent with guardian consent
排除标准
- •MRI or LIFU contraindications
- •Recent investigational drug/device use
- •Neurological illness (e.g., epilepsy, TBI)
- •Substance use disorder
- •Sensory/motor impairments preventing task completion
研究组 & 干预措施
Active LIFU
Experimental
干预措施: Active LIFU (Device)
结局指标
主要结局
Social Responsiveness Scale, Second Edition (SRS-2)
时间窗: Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation; Visit 8, within 1 month of last stimulation)
次要结局
- Penn Emotion Identification Task(Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation; Visit 8, within 1 month of last stimulation))
- Electroencephalography (EEG) in the alpha (8-12Hz) frequency band(Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation))
- Radiological MRI Safety Scans (T1, T2, diffusion scans, read for abnormalities)(Baseline (Visit 1) to post-stimulation (Visit 7, within 1 week of last stimulation))
研究者
Kevin Caulfield
Assistant Professor
Medical University of South Carolina
研究点 (1)
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