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| Name | Class |
|---|---|
| University of Barcelona | OTHER |
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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:
For this study participants will undergo:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Controls | Experimental | Healthy controls with no history of chronic pain. |
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| Headache and Migraine | Experimental | Individuals who have migraine with headaches. |
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| Functional Abdominal Pain Disorder (FAPD) | Experimental | Individuals who have functional abdominal pain disorder. |
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| Localized and Diffuse/Widespread Musculoskeletal Pain (MSK) | Experimental | Individuals with chronic musculoskeletal pain. |
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| Complex Regional Pain Syndrome (CRPS) | Experimental | Individuals with complex regional pain syndrome. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multisensory Task | Other | Reversing checkerboard, tones, and finger opposition. |
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| Measure | Description | Time Frame |
|---|---|---|
| FMRI: BOLD resting connectivity of the amygdala | BOLD resting connectivity of the amygdala | Baseline |
| Resting Cerebral Blood Flow (CBF) | CBF derived from resting arterial spin labeled MRI | Baseline |
| FMRI: Multisensory task activity | BOLD activation during multisensory task | Baseline |
| FMRI: Spatial task activity | BOLD activation during spatial summation and divided attention | Baseline |
| FMRI: BOLD resting connectivity of the posterior parietal cortex | BOLD resting connectivity of the posterior parietal cortex | Baseline |
| FMRI: Graphesthesia Activation | BOLD activation during graphesthesia task | Baseline |
| Pain Ratings | 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. | Baseline |
| Pain Ratings | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Catherine Jackson, MSc | Contact | 5136360669 | Catherine.Jackson@cchmc.org | |
| Hannah Schildmeyer, BS | Contact | Hannah.Schildmeyer@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Robert Coghill, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital | Recruiting | Cincinnati | Ohio | 45229 | United States |
Data That Will Be Shared:
Data sharing represents a critical dimension of the proposed research. The data will be quite complex with psychological, psychophysical, demographic information collected outside of the scanner, and multiple modalities of MRI information collected during scanning. Accordingly, this rich dataset can be utilized for many secondary analyses. All modalities of data will be shared, with raw data included.
Formatting of Data to Facilitate Sharing:
As data is acquired, it will be named and placed into directory structures according to the BIDS standard (Brain Imaging Database Structure: http://bids.neuroimaging.io/). This standard accommodates all types of neuroimaging data to be acquired in the present proposal, and also allows for the inclusion of non-neuroimaging data such as psychological, psychophysical, and demographic information. Importantly, when data is in this format, it can be readily shared within OpenFMRI and other data warehouses
Data will be made available after publication of key papers and will be permanently available with no expiration date.
After publication of key papers, data will be freely available for all researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 10, 2023 | Feb 22, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2023 | Feb 22, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 28, 2023 | Mar 28, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D020918 | Complex Regional Pain Syndromes |
| D059352 | Musculoskeletal Pain |
| D005356 | Fibromyalgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| Graphesthesia | Other | Trace numbers on skin. |
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| Divided attention | Other | Divide attention between two noxious stimuli. |
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| 1 Year Followup |
| Spatial Distribution of Pain | Body map assessment of location of pain | Baseline |
| Spatial Distribution of Pain | Body map assessment of location of pain | 1 Year Followup |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012216 | Rheumatic Diseases |