Clinical trial NCT05197946: Anatomical and Functional Imaging Correlates of Chronic Pain in Cerebral Palsy
Official title: Anatomical and Functional Imaging Correlates of Chronic Pain in Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Palsy
Chronic Pain
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Mount Washington Pediatric Hospital
name: Neurosurgery Pain Research Institute
name: Cerebral Palsy Alliance
First posted: 2022-01-20
Enrollment: 300
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and adults with cerebral palsy and typically-developing adults and children

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.

Detailed description: Background: Seventy percent of adults with cerebral palsy (CP) have chronic pain. Patterns in pain symptoms suggest that different individuals have different types of pain. People with CP have differences in brain structure and function, but links with pain mechanisms are not well-understood. Better understanding could help inform precision diagnosis and management of pain subtypes in individuals with CP.

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.

Eligibility criteria: Participants with CP (Survey-only):

Inclusion Criteria:

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

Exclusion Criteria:

-None

Neurotypical participants: (Survey-only):

Inclusion Criteria:

* 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

Exclusion Criteria:

-Clinically-significant neurologic or developmental diagnosis

Participants with CP (Survey and MRI):

Inclusion Criteria:

* 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

Exclusion Criteria:

-None

Neurotypical participants (Survey and MRI):

Inclusion Criteria:

* 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:

-Clinically-significant neurologic or developmental diagnosis

Primary outcomes:
measure: Regional brain/spine volumes
timeFrame: <3 months
measure: Diffusion scalars
timeFrame: <3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: F.M. Kirby Center
state: Maryland
city: Baltimore
country: United States
facility: Mt. Washington Pediatric Hospital
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Eric Chin, MD
role: PRINCIPAL_INVESTIGATOR
References: