Pilot Study of the Use of Functional Near-Infrared Spectroscopy (fNIRS) Combined With Diffuse Correlation Spectroscopy (DCS) in Neurocognitive Disease as Compared to Healthy Neurotypical Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Proportion of individuals who complete the study relative to those in which data collection was attempted
研究概览
简要总结
Background:
Neurocognitive disorders affect how the brain uses oxygen. They may affect mental development in children. These disorders can be studied with imaging scans that use radiation; however, these methods are not ideal for research on children. Two technologies-functional near-infrared spectroscopy (fNIRS) and diffuse correlation spectroscopy (DCS)-use light to detect changes in brain activity. These methods are safer, and they can be used in a more relaxed setting. In this natural history study, researchers want to find out whether fNIRS and DCS can be a good way to study people with neurocognitive disorders.
Objective:
To find out whether fNIRS and DCS can be useful in measuring brain activity in people with neurocognitive disorders.
Eligibility:
People aged 6 months or older with neurocognitive disorders. These can include Niemann-Pick disease type C1 (NPC1); creatine transporter deficiency (CTD); Smith Lemli Opitz syndrome (SLOS); juvenile neuronal ceroid lipofuscinosis (CLN3 disease); and Pheland-McDermid (PMS) syndrome. Healthy volunteers are also needed.
Design:
Participants will have a physical exam. They will have tests of their memory and thinking.
Participants will sit in a quiet room for the fNIRS and DCS tests. A snug cap (like a cloth swim cap) will be placed on their head. The cap has lights and sensors. Another sensor will be placed on their forehead. Participants will perform tasks on a computer. This testing will take 45 to 60 minutes.
The tests will be repeated within 1 to 4 weeks. Participants will be asked to return for repeat tests 1 year later.
详细描述
Study Description:
Brain hypometabolism has been observed in neurologic conditions. These data were obtained using modalities that involved radiation exposure and were not easily amenable to being combined with performance of functional tasks. Functional near-infrared spectroscopy (fNIRS) and Diffusion Correlation Spectroscopy (DCS) are noninvasive, easy-to-use, and portable brain imaging technology that enable studies of metabolic parameters and their alterations with task performance in neurotypical and neurocognitively affected individuals. Specifically, it enables the study of brain oxygen utilization which likely correlates with brain metabolism. We are proposing a pilot study of the use of fNIRS and DCS in neurocognitive disorders that have been extensively followed in our groups: Niemann-Pick disease type C1 (NPC1), creatine transporter deficiency (CTD), Smith Lemli Opitz syndrome (SLOS), Juvenile Neuronal Ceroid Lipofuscinosis (CLN3 disease), and Phelan-McDermid (PMS) syndrome. We want to compare findings in these populations to neurotypical healthy controls.
Objectives:
The primary objective of this pilot study is to determine the feasibility of fNIRS-DCS in individuals with neurocognitive-related disorders.
The secondary objectives of this study are:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 110 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •For both study populations (Affected and Typically Developing group):
- •Male or female, aged 6 months and up
- •English is the primary language spoken at home
- •For study population (Affected group):
- •-Neurocognitive-related conditions including SLOS, CLN3, CTD, NPC and PMS.
- •For controls (Typically Developing Group):
- •In good general health as determined by medical history and physical exam
排除标准
- •For both study populations (Affected and Typically Developing group):
- •Any condition that may affect placement of the fNIRS-DCS
- •Past or present vascular disease
- •Traumatic loss of consciousness in the last year
- •Any condition which, in the opinion of the investigator, increases risk of participation or affects adherence to the protocol
- •For controls (Typically Developing Group):
- •Known or suspected cognitive impairment
- •Known history of MRI abnormality
- •Current use of psychotropic medications
研究组 & 干预措施
2
individuals with known neurocognitive disorders (i.e. affected)
1
individuals without known health or medical issues (i.e. healthy volunteers)
结局指标
主要结局
Proportion of individuals who complete the study relative to those in which data collection was attempted
时间窗: 2 years
We hypothesize that fNIRS and DCS will show low rates of adverse events across all participants (\<5%) and high rates of completed fNIRS-DCS data collections (\> 75%).
Adverse events
时间窗: 2 years
We hypothesize that fNIRS and DCS will show low rates of adverse events across all participants (\<5%) and high rates of completed fNIRS-DCS data collections (\> 75%).
次要结局
- Cerebral activation, measured via O2 changes, in resting and in active state(2 years)
- Cerebral blood flow in resting and active state(2 years)