Auricular Transcutaneous Electrical Nerve Stimulation Treatment of Autism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Autism Treatment Evaluation Checklist (ATEC)
研究概览
简要总结
In this study, investigators will examine the treatment effects of transcutaneous electrical nerve stimulation with different stimulation frequencies on individuals with autism.
详细描述
In this study, investigators will examine the treatment effect of transcutaneous electrical nerve stimulation at auricular area with vagus nerve distribution on high-functioning individuals with autism. Specifically, investigators will choose two ear acupoints: heart and shenmen. Participants will be randomized to either 1 Hz or 20 Hz tVNS group (up to 5 times per week) for three weeks.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autism diagnosed based on DSM-V classification criteria
- •18-60 year old high functioning adult autism patients (e.g. Asperger's, IQ equal or greater than 80)
- •Subjects who do not show aggressive behaviors based on neuro/psychiatric evaluations as determined by a licensed study physician.
排除标准
- •A history of chronic serious infection, any current infection, any type of cancer or autoimmune disease or other severe diseases;
- •Subjects taking any medications that confound the study results
研究组 & 干预措施
20 Hz group
20 Hz Auricular transcutaneous electrical nerve stimulation High-functioning individuals with autism randomized to this group will receive 20 Hz tVNS stimulation for 30 minutes/day up to 5 times/week for 3 weeks.
干预措施: 20 Hz Auricular transcutaneous electrical nerve stimulation (Other)
1 Hz group
1 Hz Auricular transcutaneous electrical nerve stimulation High-functioning individuals with autism randomized to this group will receive 1 Hz tVNS stimulation for 30 minutes/day up to 5 times/week for 3 weeks.
干预措施: 1 Hz Auricular transcutaneous electrical nerve stimulation (Other)
结局指标
主要结局
Change in Autism Treatment Evaluation Checklist (ATEC)
时间窗: Baseline and after 3-week treatment
ATEC will be reported by investigator in a total and for each of the 4 subscales as follows: (1) speech/language/communication subscale; (2) social subscale; (3) sensory and cognitive awareness subscale; and (4) health / physical / behavior problem subscale. The total score ranges from 0 to 179; a higher score indicated worsening while a lower score indicated improvement.
次要结局
- Autonomic measurements via wristband photoplethysmograph (PPG) sensor (optional)(Baseline and after 3-week treatment)
- Change in Aberrant Behavior Checklist (ABC)(Baseline and after 3-week treatment)
- Change in Sleep Quality Assessment (PSQI)(Baseline and after 3-week treatment)
- EEG (optional)(Baseline and after 3-week treatment)
- Salivary oxytocin quantification (optional)(Baseline and after 3-week treatment)
- Change in Clinical Global Impression-Improvement (CGI-I)(Baseline and after 3-week treatment)
- Change in PROMIS Sleep Disturbance Short Form(Baseline and after 3-week treatment)
- PROMIS-29(Baseline and after 3-week treatment)
- Pulse oximetry measurements (optional)(Baseline and after 3-week treatment)
- Change in Penn State Worry Questionnaire(Baseline and after 3-week treatment)
- Quantification of species-level L. reuteri abundance in human stool samples (optional)(Baseline and after 3-week treatment)
- ECG (optional)(Baseline and after 3-week treatment)
研究者
Jian Kong
Associate Professor
Massachusetts General Hospital