Safety and Efficacy of Transcranial Photobiomodulation (tPBM) for Individuals With Autism Spectrum Disorder and Epileptiform Activity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Childhood Autism Rating Scores (CARS)
研究概览
简要总结
For this study, the proposed intervention will be noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brains of autistic children with abnormal EEGs with epileptiform discharges or with epilepsy. This will occur, twice a week, for 10 weeks. The NIR light is delivered to specific brain areas by Cognilum, a wearable device developed by Jelikalite. The expected outcome is improved focus, improved eye contact, improved speech, improved behavior, and gains in functional skills. Cognilum may impact the clinical practice of treating autism. At the beginning, at five weeks, and at the end of study, the clinician will complete the CARS-2, SRS, CGI, and a caregiver interview; additionally, questionnaires will be administered to caregivers during one of the 1-hour weekly treatment sessions.
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
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autism Spectrum Disorder (diagnosed as Autistic Disorder on the ADOS-2 or the ADI-R).
- •Between 4 and 12 years of age, at baseline.
- •Autism severity of moderate or higher (≥4) under the 7-item clinical global impression-severity scale. Moderate level of autism severity (4) is defined by the diagnosis of ASD with language impairment.
- •Ability to maintain all ongoing complementary, dietary, traditional, and behavioral treatments constant for the study period.
- •Unchanged complementary, dietary, traditional, and behavioral treatments for two months prior to study entry
- •Ability to tolerate procedures, as determined at the discretion of the investigator.
- •At least one 24hr EEG with data in EDF format that is accessible to investigators.
排除标准
- •Significant self-abusive or violent behavior or evidence of suicidal ideation, plan or behavior
- •Severely affected children as defined by CGI-Severity Standard Score = 7 (Extremely Ill)
- •Severe prematurity (<34 weeks gestation) as determined by medical history
- •Current uncontrolled gastroesophageal reflux disease since GERD can cause movements that appear like seizures
- •Genetic syndromes
- •Congenital brain malformations
- •Any medical condition that the PI determines could jeopardize the safety of the study subject or compromise the integrity of the data.
- •Failure to thrive or Body Mass Index < 5%ile or <5%ile for weight (male <11.2kg; female <10.8kg by CDC 2000 growth charts) at the time of the study.
- •Concurrent treatment with drug that would significantly interact with treatment.
- •• Stimulants
- •• Anti-Psychotics
- •• Antihistamines
- •Excessive Hair that the caregivers are unwilling or unable to shave or braid.
- •Inability to tolerate the required dosage of tPBM treatment due to sensory issues.
研究组 & 干预措施
Near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) - to the brain of autistic child
This is a prospective, open level study comparing 15 individuals with active seizures and 15 individuals with EEG abnormalities before and after, near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) will be the active arm
干预措施: noninvasively delivered near infra-red (NIR) light - transcranial Photobiomodulation (tPBM) (Device)
结局指标
主要结局
Childhood Autism Rating Scores (CARS)
时间窗: Baseline, Week 11 and Week 15 (One Month Follow-Up)
The CARS is a measure of autism severity completed by a clinician. Lower Score is Better. Scores range from 15 to 60.
Childhood Autism Rating Scores (CARS)
时间窗: Baseline, Week 5, Week 11 and Week 15 (One Month Follow-Up)
The CARS is a measure of autism severity completed by a clinician. Lower Score is Better. Scores range from 15 to 60.
次要结局
- EEG Delta Power(Before Treatment and EEG following treatment (within 6 months))
研究者
Richard Frye
Principal Investigator and Sponsor
Rossignol Medical Center