Integrated Platform for Measuring and Reducing Symptoms of Autism Spectrum Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Childhood Autism Rating Scale, Second edition
研究概览
简要总结
This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University and Mt. Sinai Medical Center with 80 autistic children evaluating the effects of transcranial photobiomodulation (tPBM) on multiple clinically validated scales.
详细描述
The proposed intervention will noninvasively deliver near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The Cognilum system is a non-invasive headband medical device specifically designed to safely and comfortably deliver tPBM to autistic children. Cognilum has been designated as a non-significant risk breakthrough device by the Food and Drug Administration. This study will consist of a randomized, double-blind, sham-controlled clinical trial at SUNY Upstate Medical University and Mt. Sinai with 80 autistic children using Cognilium device and measuring the impact using multiple clinically validated scales.
Hypothesis 1: Significant reduction of average Childhood Autism Rating Scores (CARS; before and after treatment comparison) in the active group compared to sham-control group.
Hypothesis 2: Significant change in average scores (before and after treatment comparison) on the Social Responsiveness Scale (SRS), and Clinical Global Impression - Improvement (CGI-I) scale in the active group compared to sham control group.
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
All participants and their caregivers will be held blind to group assignment. The PI will also remain blind to participant group assignment and conduct the pre- and post-assessment batteries (i.e., CARS-2, SRS, and CGI-I). Two clinical research assistants and co-investigator, will randomly assign participants to groups and have knowledge of their assignment. A third research assistant will also be held blind to group assignment and complete weekly interviews with caregivers.
入排标准
- 年龄范围
- 2 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 2 - 8
- •Autism spectrum disorder diagnosis
- •CARS-2 score of 30 - 45
排除标准
- •CARS scores less than 30 or over
- •Taking psychotropic medications.
- •Having skin lesions on scalp
- •Having history of seizures
- •Having history of abnormal EEG
- •Being a relative of the PI or a researcher
- •Having implanted devices (including cochlear implants).
研究组 & 干预措施
CognilumTM
During the study participants will be wear the transcranial photobiomodulation device Cognilum. The device will administer the stimulation of near infrared light (830nm) to specific areas of the child's brain.
干预措施: Cognilum TM: Light Treatment Condition (Device)
Sham control
During the study participants will wear the transcranial photobiomodulation device. The device will not be turned on and therefore no brain stimulation with near infrared light (830nm) will be provided.
干预措施: Cognilum TM: Light Treatment Condition (Device)
结局指标
主要结局
Childhood Autism Rating Scale, Second edition
时间窗: 10 weeks
Psychometrically sound measure for identifying children with autism and their symptom severity through quantifiable ratings based on direct observation. Raw scores may range from 15 to 60, which are then converted to T-scores. Higher scores indicate greater severity.
次要结局
- Clinical Global Impressions Scale(10 weeks)
- Social Responsiveness Scale, Second Edition(10 weeks)