Anatomical and Functional Imaging Correlates of Chronic Pain in Cerebral Palsy
NCT ID: NCT05197946
Last Updated: 2025-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2018-12-04
2026-04-07
Brief Summary
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Detailed Description
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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
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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of cerebral palsy
* 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
* 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
* 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
Neurotypical participants: (Survey-only):
-Clinically-significant neurologic or developmental diagnosis
Participants with CP (Survey and MRI):
-None
Neurotypical participants (Survey and MRI):
-Clinically-significant neurologic or developmental diagnosis
8 Years
ALL
Yes
Sponsors
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Johns Hopkins University
OTHER
Mount Washington Pediatric Hospital
UNKNOWN
Neurosurgery Pain Research Institute
UNKNOWN
Cerebral Palsy Alliance
OTHER
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
OTHER
Responsible Party
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Principal Investigators
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Eric Chin, MD
Role: PRINCIPAL_INVESTIGATOR
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Locations
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F.M. Kirby Center
Baltimore, Maryland, United States
Mt. Washington Pediatric Hospital
Baltimore, Maryland, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB00181801
Identifier Type: -
Identifier Source: org_study_id
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