Recruiting

Observational Study

Sponsor:

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

Code:

NCT05197946

Conditions

Cerebral Palsy

Chronic Pain

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Accepted

Interventions

MRI

Study Details

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

Study ID

NCT05197946

Start date

Dec 4, 2018

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Paul Salib, MS

(443) 923-9272CPpainStudy@kennedykrieger.org

Eric Chin, MD

(443) 923-9141CPpainStudy@kennedykrieger.org

Locations

F.M. Kirby Center

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Eric Chin, MD

443-923-9141CPpainStudy@kennedykrieger.org

Mt. Washington Pediatric Hospital

Recruiting

Baltimore, Maryland, United States, 21209

Contacts

Stephen Nichols, MD

410-578-8600snichols@mwph.org

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Shenandoah Robinson, MD

667-208-9378srobin81@jhmi.edu

Kennedy Krieger Institute

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Eric Chin, MD

443-923-9141chine@kennedykrieger.org

More Information

Sponsor

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

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. on 2026-06-29.