Health TrialsbyHealthPanel

Anatomical and Functional Imaging Correlates of Chronic Pain in Cerebral Palsy

ConditionsCerebral PalsyChronic Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age8+
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

Individual 8+ years of age

Diagnosis of cerebral palsy

Disqualifiers

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

Trial population

Children and adults with cerebral palsy and typically-developing adults and children

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: Participants with CP (survey-only)0 interventions
Group B: Neurotypical participants (survey-only)0 interventions
Group C: Participants with CP (Survey + MRI)1 intervention
Group D: Neurotypical participants (Survey + MRI)1 intervention

Trial outcomes

Primary outcomes

1

Regional brain/spine volumes

Regional volumes will be measured using MR processing software

Time frame
<3 months
2

Diffusion scalars

Diffusion scalars for tracts of interest including the posterior thalamic radiations as well as somatosensory association fibers and the spinothalamic tract

Time frame
<3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Johns Hopkins University

Collaborator

Mount Washington Pediatric Hospital

Collaborator

Neurosurgery Pain Research Institute

Collaborator

Cerebral Palsy Alliance

Collaborator

Source ClinicalTrials.gov
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