Anatomical and Functional Imaging Correlates of Chronic Pain in Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 8
- 主要终点
- Regional brain/spine volumes
研究概览
简要总结
The investigators hope to use MRI biomarkers to identify and characterize sensorimotor network disruption patterns associated with chronic pain and sensory deficits in CP. Investigators will use existing information in the medical record as well as subjective reports from interview, physical exam data, and anatomical and functional MRI data to non-invasively identify brain injury correlates of pain and sensory deficits.
详细描述
Background: Seventy percent of adults with cerebral palsy (CP) have chronic pain. Patterns in pain symptoms suggest that different individuals have different types of pain. People with CP have differences in brain structure and function, but links with pain mechanisms are not well-understood. Better understanding could help inform precision diagnosis and management of pain subtypes in individuals with CP.
Objectives:
Primary: Identify and characterize sensorimotor network disruption patterns associated with chronic pain and motor deficits in CP
Secondary:
- Improve understanding of anatomical brain network changes in CP associated with sensory deficits and pain
- Identify non-invasive imaging-based neurobiomarkers applicable to sensory loss and pain in CP
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with CP (Survey-only):
- •Inclusion Criteria:
- •Individual 8+ years of age
- •Diagnosis of cerebral palsy
排除标准
- •Neurotypical participants: (Survey-only):
- •Inclusion Criteria:
- •Individual 8+ years of age
- •Adult subject able to indicate understanding and affirmative consent OR Adult/child subject unable to indicate understanding and affirmative consent AND subject assents AND LAR consents
- •Exclusion Criteria:
- •Clinically-significant neurologic or developmental diagnosis
- •Participants with CP (Survey and MRI):
- •Inclusion Criteria:
- •Individual 8+ years of age
- •Adult subject able to indicate understanding and affirmative consent OR Adult subject unable to indicate understanding and affirmative consent AND subject assents AND LAR consents
- •Diagnosis of cerebral palsy
- •Clinical imaging demonstrating isolated periventricular white matter injury
- •Clinical judgment that all neurologic symptoms are attributable to non-progressive periventricular white matter injury
- •Able to lie still in scanner for 1.5 hours in at most 2 sessions and be able to have MRI
- •Exclusion Criteria:
- •Neurotypical participants (Survey and MRI):
- •Inclusion Criteria:
- •Individual 8+ years of age
- •Adult subject able to indicate understanding and affirmative consent
- •Able to lie still in scanner for 1.5 hours and be able to have MRI
- •Exclusion Criteria:
- •Clinically-significant neurologic or developmental diagnosis
研究组 & 干预措施
Participants with CP (survey-only)
Subjects in this group are age 8 and older with a diagnosis of cerebral palsy. Participants are either able to affirmatively consent or assent with LAR consent. This sample will have a CFCS score ranging between 1 and 3 and should be able to unambiguously respond to a 65 item multiple choice survey.
Neurotypical participants (survey-only)
Subjects in this group are age 8 and older with no clinically significant neurologic or developmental diagnosis. Participants are either able to affirmatively consent or assent with LAR consent.
Participants with CP (Survey + MRI)
Subjects are 8 years or older with a diagnosis of cerebral palsy and clinical imaging demonstrating isolated periventricular white matter injury. Clinical assessment states that neurologic symptoms are attributed to this isolated injury. Subjects in this group must be able to lie still in a scanner for 1.5 hours in at most 2 sessions and be able to have an MRI. Participants must be able to affirmatively consent or assent with LAR consent.
干预措施: MRI (Diagnostic Test)
Neurotypical participants (Survey + MRI)
Subjects in this group are age 8 and older with no clinically significant neurologic or developmental diagnosis. Participants are able to affirmatively consent and are able to have an MRI. Subjects also should be able to lie still in a scanner for 1.5 hours.
干预措施: MRI (Diagnostic Test)
结局指标
主要结局
Regional brain/spine volumes
时间窗: <3 months
Regional volumes will be measured using MR processing software
Diffusion scalars
时间窗: <3 months
Diffusion scalars for tracts of interest including the posterior thalamic radiations as well as somatosensory association fibers and the spinothalamic tract
次要结局
未报告次要终点