Anatomical and Functional Imaging Correlates of Chronic Pain in Cerebral Palsy

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study ID
NCT05197946
Status
Recruiting
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Conditions

  • Cerebral Palsy
  • Chronic Pain

Eligibility Criteria

Sex
ALL
Age
8 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 4, 2018
Status verified
May 2025
Primary completion
Apr 7, 2026
Completion
Apr 7, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Regional brain/spine volumes [ Time Frame: <3 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
F.M. Kirby CenterBaltimoreMaryland21205
Eric Chin, MD
[email protected]
443-923-9141
Johns Hopkins HospitalBaltimoreMaryland21287
Shenandoah Robinson, MD
[email protected]
667-208-9378
Kennedy Krieger InstituteBaltimoreMaryland21287
Eric Chin, MD
[email protected]
443-923-9141
Mt. Washington Pediatric HospitalBaltimoreMaryland21209
Stephen Nichols, MD
[email protected]
410-578-8600

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By research site
F.M. Kirby Center· Baltimore, MDJohns Hopkins Hospital· Baltimore, MDKennedy Krieger Institute· Baltimore, MDMt. Washington Pediatric Hospital· Baltimore, MD

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