■小型试点研究表明,经颅光生物调节(tPBM)可以帮助减轻神经系统疾病的症状,比如抑郁症,创伤性脑损伤,和自闭症谱系障碍(ASD)。
■检查tPBM对2至6岁儿童ASD症状的影响。
■我们进行了随机,假对照临床试验,涉及30名2至6岁的儿童,先前诊断为ASD。我们发出近红外光脉冲(40赫兹,850nm)每周两次对选定的大脑区域进行非侵入性检查,持续八周,使用为此目的设计的研究性医疗设备(Cognilum™,JelikaLite公司,纽约,美国)。我们使用了儿童自闭症评定量表(CARS,第2版),以评估和比较治疗过程前后参与者的ASD症状。我们在每次会议期间从那些耐受佩戴EEG帽的参与者收集脑电图(EEG)数据。
■两组之间的CARS评分变化差异为7.23(95%CI为2.357至12.107,p=0.011)。30名参与者中有17人完成了至少两个EEG,并检测到了与时间相关的趋势。此外,在增量功率(系数=7.521,95%CI-0.517至15.559,p=0.07)和θ功率(系数=-8.287,95%CI-17.199至0.626,p=0.07)中观察到有效与假与缩放时间之间的相互作用,表明活性组的治疗随着时间的推移,δ功率有更大的降低和θ功率增加的潜在趋势,与Sham组相比。此外,病情有显著差异(治疗与假)的θ波功率(净θ)(系数=9.547,95%CI0.027至19.067,p=0.049)。试验期间未报告或观察到中度或重度副作用或不良反应。
■这些结果表明,tPBM可能是ASD的安全有效治疗方法,应在更大的研究中进行更深入的研究。临床试验注册:https://clinicaltrials.gov/ct2/show/NCT04660552,标识符NCT04660552。
UNASSIGNED: Small pilot studies have suggested that transcranial photobiomodulation (tPBM) could help reduce symptoms of neurological conditions, such as depression, traumatic brain injury, and autism spectrum disorder (ASD).
UNASSIGNED: To examine the impact of tPBM on the symptoms of ASD in children aged two to six years.
UNASSIGNED: We conducted a randomized, sham-controlled clinical trial involving thirty children aged two to six years with a prior diagnosis of ASD. We delivered pulses of near-infrared light (40 Hz, 850 nm) noninvasively to selected brain areas twice a week for eight weeks, using an investigational medical device designed for this purpose (Cognilum™, JelikaLite Corp., New York, United States). We used the Childhood Autism Rating Scale (CARS, 2nd Edition) to assess and compare the ASD symptoms of participants before and after the treatment course. We collected electroencephalogram (EEG) data during each session from those participants who tolerated wearing the EEG cap.
UNASSIGNED: The difference in the change in CARS scores between the two groups was 7.23 (95% CI 2.357 to 12.107, p = 0.011). Seventeen of the thirty participants completed at least two EEGs and time-dependent trends were detected. In addition, an interaction between Active versus Sham and Scaled Time was observed in delta power (Coefficient = 7.521, 95% CI -0.517 to 15.559, p = 0.07) and theta power (Coefficient = -8.287, 95% CI -17.199 to 0.626, p = 0.07), indicating a potential trend towards a greater reduction in delta power and an increase in theta power over time with treatment in the Active group, compared to the Sham group. Furthermore, there was a significant difference in the condition (Treatment vs. Sham) in the power of theta waves (net_theta) (Coefficient = 9.547, 95% CI 0.027 to 19.067, p = 0.049). No moderate or severe side effects or adverse effects were reported or observed during the trial.
UNASSIGNED: These results indicate that tPBM may be a safe and effective treatment for ASD and should be studied in more depth in larger studies.Clinical trial registration: https://clinicaltrials.gov/ct2/show/NCT04660552, identifier NCT04660552.