NCT05197946 · Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Anatomical and Functional Imaging Correlates of Chronic Pain in Cerebral Palsy
What this study is about
The investigators hope to use MRI biomarkers to identify and characterize sensorimotor network disruption patterns associated with chronic pain and sensory deficits in CP.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
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.
Primary outcome measures
Regional brain/spine volumes
Time frame: <3 months
Regional volumes will be measured using MR processing software
Diffusion scalars
Time frame: <3 months
Diffusion scalars for tracts of interest including the posterior thalamic radiations as well as somatosensory association fibers and the spinothalamic tract
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Baltimore, Maryland
Collaborators
Johns Hopkins University, Mount Washington Pediatric Hospital, Neurosurgery Pain Research Institute, Cerebral Palsy Alliance
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 29, 2026 · Source of record for eligibility and locations