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临床试验/NCT05814497
NCT05814497招募中不适用

Supraspinal Processing of Sensory Aspects of Pain

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2023年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
255
试验地点
2
主要终点
Spatial Distribution of Pain

研究概览

简要总结

The goal of this basic science study is to learn about the brain mechanisms of chronic pain across different chronic pain syndromes in pediatric patients. The main questions it aims to answer are:

  • Are there shared and distinct brain systems engaged by different forms of pediatric chronic pain?
  • What are predictors of recovery from chronic pain?
  • What brain systems are associated with the spread of pain?

For this study participants will undergo:

  • Functional Magnetic Resonance Imaging (fMRI)
  • Quantitative Sensory Testing
  • Psychological Assessments

详细描述

Chronic pain affects approximately 20% of both adults and children in the US and is a source of substantial disability and health care costs. Chronic pain can be challenging to diagnose due to the presence of poorly understood symptoms. When diagnosed, current pharmacologic treatments for pain are remarkably ineffective, while effective non-pharmacologic treatments remain under-utilized. These shortcomings in the diagnosis and treatment of pain arise from tremendous gaps in our knowledge about the basic central nervous system systems that process nociceptive information and instantiate an experience of pain. These gaps are further amplified in the case of pediatric chronic pain due to a lack of basic/translational research. The team of basic scientists and clinician scientists is uniquely positioned to perform human pediatric studies integrating functional neuroimaging with quantitative sensory testing and psychological assessments to delineate brain systems engaged during chronic pain. The study will examine four distinct chronic pain syndromes: migraine, complex regional pain syndrome, functional abdominal pain, and musculoskeletal pain. The study seeks to 1) Identify shared and distinct brain systems engaged by different forms of pediatric chronic pain, 2) Determine if predictors of recovery differ across different chronic pain conditions, 3) Delineate brain systems associated with the spread of pain. To accomplish these aims, the study will recruit 400 patients with chronic pain and 100 healthy participants (age range 10-17). The study will follow all participants longitudinally for 1 year after initiation of treatment to assess the degree of recovery and spread of pain. This basic science investigation will provide a critical foundation of basic knowledge for future clinical trials of diagnostic markers for different forms of chronic pain and for the development of new treatments for chronic pain.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients will need a diagnosis of a chronic pain derived congruent with ICD-11 criteria related to headache (migraine, daily headache), abdominal (FAPD), localized MSK (single limb/joint, low back or chest pain), diffuse MSK (widespread MSK pain), or CRPS
  • If on medications, they need to be on stable doses of prescribed pain and/or psychiatric medications for 4 weeks before the baseline study visit.
  • Male or female, age 10 -17 (inclusive)
  • English speaking, able to complete interviews and questionnaires in English

排除标准

  • Weight/size incompatible with MRI scanner
  • Orthodontic braces, metallic or electronic implants, or other metal objects in the body which obscure or interfere with the MRI, or pose a risk from heating, movement, or malfunction in the MRI environment
  • Claustrophobia
  • Youth who are pregnant
  • Any comorbid rheumatic disease, diagnosis of epilepsy, other neurological diseases, or medical condition (e.g. diabetes, cancer, IBD)
  • Present psychiatric disease as defined by DSM IV (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, ADHD, or mental retardation) that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study
  • Skin conditions or past skin damage on the arms or legs in or near sites of sensory testing
  • Outside the age range (9 years old or younger; 18 years or older) at the time of consent
  • History of > 1 month opioid treatment.

研究组 & 干预措施

Healthy Controls

Experimental

Healthy controls with no history of chronic pain.

干预措施: Multisensory Task (Other)

Healthy Controls

Experimental

Healthy controls with no history of chronic pain.

干预措施: Graphesthesia (Other)

Healthy Controls

Experimental

Healthy controls with no history of chronic pain.

干预措施: Divided attention (Other)

Headache and Migraine

Experimental

Individuals who have migraine with headaches.

干预措施: Multisensory Task (Other)

Headache and Migraine

Experimental

Individuals who have migraine with headaches.

干预措施: Graphesthesia (Other)

Headache and Migraine

Experimental

Individuals who have migraine with headaches.

干预措施: Divided attention (Other)

Functional Abdominal Pain Disorder (FAPD)

Experimental

Individuals who have functional abdominal pain disorder.

干预措施: Multisensory Task (Other)

Functional Abdominal Pain Disorder (FAPD)

Experimental

Individuals who have functional abdominal pain disorder.

干预措施: Graphesthesia (Other)

Functional Abdominal Pain Disorder (FAPD)

Experimental

Individuals who have functional abdominal pain disorder.

干预措施: Divided attention (Other)

Localized and Diffuse/Widespread Musculoskeletal Pain (MSK)

Experimental

Individuals with chronic musculoskeletal pain.

干预措施: Multisensory Task (Other)

Localized and Diffuse/Widespread Musculoskeletal Pain (MSK)

Experimental

Individuals with chronic musculoskeletal pain.

干预措施: Graphesthesia (Other)

Localized and Diffuse/Widespread Musculoskeletal Pain (MSK)

Experimental

Individuals with chronic musculoskeletal pain.

干预措施: Divided attention (Other)

Complex Regional Pain Syndrome (CRPS)

Experimental

Individuals with complex regional pain syndrome.

干预措施: Graphesthesia (Other)

Complex Regional Pain Syndrome (CRPS)

Experimental

Individuals with complex regional pain syndrome.

干预措施: Multisensory Task (Other)

Complex Regional Pain Syndrome (CRPS)

Experimental

Individuals with complex regional pain syndrome.

干预措施: Divided attention (Other)

结局指标

主要结局

Spatial Distribution of Pain

时间窗: 1 Year Followup

Body map assessment of location of pain

FMRI: BOLD resting connectivity of the amygdala

时间窗: Baseline

BOLD resting connectivity of the amygdala

Resting Cerebral Blood Flow (CBF)

时间窗: Baseline

CBF derived from resting arterial spin labeled MRI

FMRI: Multisensory task activity

时间窗: Baseline

BOLD activation during multisensory task

FMRI: Spatial task activity

时间窗: Baseline

BOLD activation during spatial summation and divided attention

FMRI: Graphesthesia Activation

时间窗: Baseline

BOLD activation during graphesthesia task

Pain Ratings

时间窗: 1 Year Followup

Visual analog scale (VAS) ratings of pain intensity and pain unpleasantness. The VAS is a scale of 0-10, with higher scores indicating a worse outcome.

FMRI: BOLD resting connectivity of the posterior parietal cortex

时间窗: Baseline

BOLD resting connectivity of the posterior parietal cortex

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Coghill

Professor

Children's Hospital Medical Center, Cincinnati

研究点 (2)

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