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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Mount Washington Pediatric Hospital | UNKNOWN |
| Neurosurgery Pain Research Institute | UNKNOWN |
| Cerebral Palsy Alliance |
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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.
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:
Procedures:
Standardized online questionnaires: Participants (individuals with CP, controls, and/or caregivers) are first asked to complete standardized questionnaires reviewing pain symptoms, demographics, and medical history (CP-related and more generally). Online questionnaires replaced Structured Interview and Physical Examination procedures at the onset of COVID safety restrictions.
Review of medical records: For consenting individuals, medical records will be requested and reviewed by the research team. Previously-acquired traditional MRI obtained for clinical purposes will be requested and reviewed to detect correlation between routine neuroimaging markers of perinatal brain injury and CP and pain. If of suitable quality, quantitative analysis methods (e.g. analysis of brain lobe and ventricular volumes for volumetric anatomical sequences, analysis of white matter volumes from DTI sequences) may be applied to prior images.
MRI: Research unsedated MRI scans (outside of usual care) will be performed using a 3T Philips scanner at the F.M. Kirby Research Center. An MRI scanning protocol will be at the F.M. Kirby Research Center; the protocol will not last more than 1.5 hours. Acquisitions will include a triplanar survey, functional and anatomical multi-slice imaging of the brain as well as MRI of selected spinal levels. Protocols will be used that do not involve use of contrast agents and limit power/tissue absorption as well as otherwise remain within FDA and Kirby Center safety regulations. When possible, MRI will be performed within 3 months of initial survey/interview administration. If MRI is scheduled >3 months after initial survey/interview administration, a brief survey will be re-administered to screen for changes in pain/clinical status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Diagnostic Test | Research unsedated MRI scans (outside of usual care) will be performed using a 3T Philips scanner at the F.M. Kirby Research Center. An MRI scanning protocol will be at the F.M. Kirby Research Center; the protocol will not last more than 1.5 hours. Acquisitions will include a triplanar survey, functional and anatomical multi-slice imaging of the brain as well as MRI of selected spinal levels. Protocols will be used that do not involve use of contrast agents and limit power/tissue absorption as well as otherwise remain within FDA and Kirby Center safety regulations. When possible, MRI will be performed within 3 months of initial survey/interview administration. If MRI is scheduled >3 months after initial survey/interview administration, a brief survey will be re-administered to screen for changes in pain/clinical status. |
| Measure | Description | Time Frame |
|---|---|---|
| Regional brain/spine volumes | Regional volumes will be measured using MR processing software | <3 months |
| Diffusion scalars | Diffusion scalars for tracts of interest including the posterior thalamic radiations as well as somatosensory association fibers and the spinothalamic tract | <3 months |
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Participants with CP (Survey-only):
Inclusion Criteria:
Exclusion Criteria:
-None
Neurotypical participants: (Survey-only):
Inclusion Criteria:
Exclusion Criteria:
-Clinically-significant neurologic or developmental diagnosis
Participants with CP (Survey and MRI):
Inclusion Criteria:
Exclusion Criteria:
-None
Neurotypical participants (Survey and MRI):
Inclusion Criteria:
Exclusion Criteria:
-Clinically-significant neurologic or developmental diagnosis
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Children and adults with cerebral palsy and typically-developing adults and children
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul Salib, MS | Contact | (443) 923-9272 | CPpainStudy@kennedykrieger.org | |
| Eric Chin, MD | Contact | (443) 923-9141 | CPpainStudy@kennedykrieger.org |
| Name | Affiliation | Role |
|---|---|---|
| Eric Chin, MD | Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| F.M. Kirby Center | Recruiting | Baltimore | Maryland | 21205 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 23, 2021 | Jan 3, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 30, 2021 | Jan 3, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| OTHER |
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| Mt. Washington Pediatric Hospital | Recruiting | Baltimore | Maryland | 21209 | United States |
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| Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21287 | United States |
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| Kennedy Krieger Institute | Recruiting | Baltimore | Maryland | 21287 | United States |
|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |