RecruitingNCT05197946

Anatomical and Functional Imaging Correlates of Chronic Pain in Cerebral Palsy


Sponsor

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Enrollment

300 participants

Start Date

Dec 4, 2018

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 8 Years

Inclusion Criteria14

  • Participants with CP (Survey-only):
  • Individual 8+ years of age
  • 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 Criteria7

  • None
  • 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

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Interventions

DIAGNOSTIC_TESTMRI

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.


Locations(4)

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

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NCT05197946


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