Anatomical and Functional Imaging Correlates of Chronic Pain in Cerebral Palsy

NCT05197946 | Recruiting

• 1 other identifier: IRB00181801
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cerebral Palsy; Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

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.

Diagnostic Test: MRI

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.

Diagnostic Test: MRI

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.

Neurotypical participants (Survey + MRI); Participants with CP (Survey + MRI)

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Individual 8+ years of age
• Diagnosis of cerebral palsy

You may not qualify if:

• None
• Neurotypical participants: (Survey-only):
• 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
• Clinically-significant neurologic or developmental diagnosis
• Participants with CP (Survey and MRI):
• 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
• None
• Neurotypical participants (Survey and MRI):
• Individual 8+ years of age

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• Johns Hopkins University: collaborator
• Mount Washington Pediatric Hospital: collaborator
• Neurosurgery Pain Research Institute: collaborator
• Cerebral Palsy Alliance: collaborator

Study Sites (4)

F.M. Kirby Center

Baltimore, Maryland, 21205, United States

RECRUITING

Mt. Washington Pediatric Hospital

Baltimore, Maryland, 21209, United States

RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Kennedy Krieger Institute

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Chronic Pain

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Chin, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Salib, MS

CONTACT

(443) 923-9272; CPpainStudy@kennedykrieger.org

Eric Chin, MD

CONTACT

(443) 923-9141; CPpainStudy@kennedykrieger.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: January 20, 2022
• Study Start: December 4, 2018
• Primary Completion: April 7, 2026
• Study Completion: April 7, 2026
• Last Updated: May 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)