Transcranial Photobiomodulation Therapy for the Treatment of Autistic Traits in Children and Adolescents With Attention Deficit Hyperactivity Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change From Baseline in Attention Deficit Hyperactivity Disorder Symptom Checklist (ADHD-SCL)
研究概览
简要总结
An open label trial to assess the safety and efficacy of transcranial photobiomodulation (tPBM) in improving autistic traits in ADHD youth.
详细描述
Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by variable presentation of difficulties with socialization, reciprocal communication, and restrictive/repetitive behaviors. An increasingly higher prevalence of ASD is documented in each successive epidemiological survey and the disorder is now estimated to affect up to 2% of youth in the general population. This rise in prevalence is in part attributed to improved recognition of autism in intellectually capable populations.
There exists no established pharmacological treatment for the core features of ASD.
Current practice consists of well-established evidence-based pharmacotherapies that are available for the management of comorbid psychiatric disorders, in order to improve quality of life and reduce symptom severity in ASD. Clinical trials of available treatment options reveal that compared to general population, individuals with ASD may be more susceptible to adverse effects of medications which could be dose-related, and may have lower adherence to treatment. New treatments for core deficits in ASD are needed; an intervention requiring no medication may offer better compliance and tolerability.
Attention Deficit/Hyperactivity Disorder (ADHD) is the most common psychiatric disorder recognized in youth and adults with ASD, and greatly adds to their morbidity and dysfunction, particularly in those with intact intellectual capacity. The prevalence of ADHD in the general population of school-age children is approximately 3% to 5%, although some reports show even higher incidence. Nearly two-thirds of referred populations of youth (ranging from 59-83%) and adults (ranging from 37-68%) with ASD suffer from ADHD.
Both ADHD and ASD have strong shared heritable components according to the evidence from twin and family studies. Up to 15% of youth with ADHD suffer from ASD and experience greater morbidity and dysfunction. This confounding effect of ASD seems to be symptom dependent and not contingent upon reaching full diagnostic threshold. In fact, up to a third of ADHD youth without ASD diagnosis still struggle with persistent symptoms of ASD (henceforth termed autistic traits [ATs]) and associated compromised outcomes. Presence of ATs is associated with a more complicated course of ADHD, characterized as increased comorbid psychopathology, more impaired interpersonal, school, family, and cognitive functioning. Anti-ADHD medications effectively mitigate core symptoms of ADHD, but offer no improvement in the ATs. Youth with ADHD continue to suffer from the impairments associated with ATs that prognosticate a compromised course in multiple domains of functioning despite effective treatment of ADHD. Treating comorbid ATs in patients with ADHD could prevent functional deterioration, and improve long term outcomes. As yet, there exists no known treatment for the core features of ASD or ATs.
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
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants between 9 and 17 years of age (inclusive)
- •Participant fulfills Diagnostic and Statistical Manual of Mental Disorders-5 diagnostic criteria for Attention Deficit Hyperactivity Disorder as established by the clinical diagnostic interview.
- •Participants with at least moderate severity of Autism Spectrum Disorder symptoms as demonstrated by Social Responsiveness Scale raw score ≥ 75 or Clinician Global Impression-Autistic Traits severity score ≥ 4
- •Participants must understand the nature of the study. Participants must sign an Institutional Review Board-approved informed consent form before initiation of any study procedures.
- •Participants are willing and able to cooperate with all tests, examinations and demonstrate ability to appropriately administer the study treatment required by the protocol.
- •Participants must have access to a computer with camera and broadband internet connection
排除标准
- •Impaired intellectual capacity (clinically determined)
- •Serious chronic medical or psychiatric condition that, in the investigator's opinion, puts the subject at risk
- •The subject has a significant skin condition at the procedure sites (i.e., hemangioma, scleroderma, psoriasis, rash, open wound or tattoo)
- •The subject has an implant of any kind in the head (e.g. stent, clipped aneurysm, embolised AVM, implantable shunt - Hakim valve)
- •Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment including: Visudine (verteporfin) - for age related macular degeneration; Aminolevulinic Acid- for actinic keratoses; Photofrin (porfimer sodium) - for esophageal cancer, non-small cell lung cancer; Levulan Kerastick (aminolevulinic acid HCl) - for actinic keratosis; 5-aminolevulinic acid; and (ALA)- for non-melanoma skin cancer
- •Current treatment with a psychotropic medication on a dose that has not been stable for at least 4 weeks prior to initiating study treatment.
- •Pregnant or nursing females
- •Investigator and his/her immediate family
结局指标
主要结局
Change From Baseline in Attention Deficit Hyperactivity Disorder Symptom Checklist (ADHD-SCL)
时间窗: Baseline to week 8
The ADHD-SCL is a clinician-rated scale used to determine the number and severity of ADHD symptoms that a patient may be experiencing. It consists of 18 items that rated on a scale from 0 (no symptoms) to 3 (severe symptoms). The item scores are combined into a total score which ranges from 0 to 54, where a higher score indicates a worse outcome. The outcome reported reflects the change from baseline in ADHD-SCL scores and negative scores represent improvement (i.e., decrease in severity from baseline).
Change From Baseline in Social Responsiveness Scale-2 (SRS-2)
时间窗: Baseline to week 8
The SRS-2 is a parent-rated scale used to identify the presence and severity of social impairment within the autism spectrum and differentiate it from that which occurs in other disorders. It consists of 65 items that rated on a scale from 1 (not true) to 4 (almost always true). Items are combined into a total score which ranges from 0 to 195, where a higher score indicates a worse outcome. The outcome reported reflects the change from baseline in SRS Total raw scores and negative scores represent improvement (i.e., decrease in severity from baseline).
次要结局
- Level of Discomfort at Study Endpoint Measured by the Transcranial Photobiomodulation Self-Report Questionnaire (TSRQ)(Week 8 (study endpoint))
研究者
Tolga A Ceranoglu
Associate Psychiatrist
Massachusetts General Hospital