Characterization of the Nociception Phenotype in Individuals With Intellectual Disability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- Provide quantitative measure of pain perception
研究概览
简要总结
Background:
People with intellectual disability (ID) often have physical disabilities as well. These physical problems can affect their bones, muscles, nerves, and gastrointestinal tracts. All of these issues can also cause pain. Yet little research has been done on pain in people with ID.
Objective:
To compare brain responses to unpleasant stimuli in people with and without ID.
Eligibility:
People aged 8 to 30 years diagnosed with an ID. Healthy volunteers without an ID are also needed.
Design:
The study requires only 1 visit of up to 4 hours. Participants with ID may come for up to 5 shorter visits instead.
Participants will take a test to measure their level of ID. They will have a physical exam.
Both groups will answer questions about pain and how their bodies react to it. They will answer questions about how they respond to things they see, feel, hear, smell, and taste. They will answer questions about their social behaviors. Caregivers may answer questions if the participant cannot.
Both groups will have a test to measure their brain activity. Participants will wear a special cap, like a swim cap, with sensors and wires. Sensors to examine the heart will be placed on the skin of their chest with stickers. An elastic band will be placed around the middle of their body to measure how fast they are breathing. Sensors to measure sweat will be placed on two fingers.
Participants will have heat, cold, brushing, and mild electrical stimuli to different parts of their body. Participants will rank how each stimulus feels using a scale with numbers or a scale with faces....
详细描述
STUDY DESCRIPTION:
The study aims to evaluate the somatosensory response to innocuous and noxious stimuli in individuals with Intellectual Disability (ID) compared to healthy controls.
OBJECTIVES:
Primary Objective:
To characterize brain activation patterns using electroencephalography (EEG) and cerebral functional-near-infrared spectroscopy (fNIRS) in response to innocuous and noxious stimulation in individuals with ID (ages, 8-30 years), compared with the brain activation pattern observed in healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •INCLUSION CRITERIA:
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •For All Participants
- •Provision of signed and dated informed consent form by participant or parent / Legally Authorized Representative (LAR) of patient.
- •Stated willingness to comply with all study procedures and availability for the duration of the study.
- •Male or female, aged 8-30 years of age.
- •Agreement to avoid use of analgesics, NSAIDs, caffeine (24 hours before procedures), illicit substances and alcohol within 2 days prior to enrollment and during study participation.
- •Healthy Adult Controls
- •IQ 85 OR General Adaptive Composite ABAS-3 score above 85
- •Must be fluent in the English Language.
- •Healthy Children
- •OR ABAS-3 score above
- •Must be fluent in the English Language.
- •Diagnosis of Intellectual Disability.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •All participants
- •NIH employees or children of NIH employee who subordinate to an investigator in this study will be excluded. This will ensure that participation or refusal to participate cannot be perceived as having any beneficial or adverse effects on their employment. There will be no direct solicitation of employees or of employees' children by the employee's supervisor.
- •Allergic reactions to EEG water based gel.
- •History of concussions in individuals with an IQ>
- •Uncontrolled seizures.
- •Pregnancy (verbal confirmation). Pregnant women will be excluded as there is no data on the effects of nociception in pregnancy.
- •For healthy volunteers only - known history of neurological, psychiatric or pain disorders.
- •History of head injury resulting in prolonged loss of consciousness in individuals with an IQ>
- •Healthy Children
- •Children who have been diagnosed with neurodevelopmental disorders or treated in early intervention programs.
- •Subjects who are on opioids, NSAID, gabapentin, or pregabalin chronically.
研究组 & 干预措施
1/ID patients
ID Patients
干预措施: TSA2 Thermosensory Stimulator (Device)
2/Healthy controls
Healthy controls
干预措施: TSA2 Thermosensory Stimulator (Device)
结局指标
主要结局
Provide quantitative measure of pain perception
时间窗: End of study
a. fNIRS: oxygenated hemoglobin. b.EEG: Theta, alpha, beta, and gamma oscillations across the cortex as measured by EEG time-frequency analysis. c. Pain thresholds (electrical perception threshold; electric tolerance threshold) d. Correlation between brain signals (oxygenated hemoglobin; theta, alpha, beta and gamma oscillations) to pain with behavioral assessments of pain, general functioning and sensory processing
次要结局
- Provides measure of pain among non-communicating individuals(End of study)