Anatomical and Functional Imaging Correlates of Chronic Pain in Cerebral Palsy

Chronic Pain Clinical Trial

Official title:

Anatomical and Functional Imaging Correlates of Chronic Pain in Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05197946
• Other study ID #: IRB00181801
• Status: Recruiting
• Start date: December 4, 2018
• Est. completion date: April 3, 2025

Study information

• Verified date: May 2024
• Source: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Contact: Paul Salib, MS
• Phone: (443) 923-9272
• Email: CPpainStudy[@]kennedykrieger.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: April 3, 2025
• Est. primary completion date: April 3, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	F.M. Kirby Center	Baltimore	Maryland
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Kennedy Krieger Institute	Baltimore	Maryland
United States	Mt. Washington Pediatric Hospital	Baltimore	Maryland

Sponsors (5)

Lead Sponsor	Collaborator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.	Cerebral Palsy Alliance, Johns Hopkins University, Mount Washington Pediatric Hospital, Neurosurgery Pain Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional brain/spine volumes	Regional volumes will be measured using MR processing software	<3 months
Primary	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