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NCT Number: NCT07433647

Evaluation of Brain MRI Changes in Cerebral Palsy Patients

Cerebral palsy (CP) is a neurodevelopmental syndrome characterized by sensorimotor impairment that arises during early childhood defined as a static insult to the developing brain. A key part of the definition for CP is a non-progressive brain injury; however, as individuals with CP age, a functional decline greater than neurotypical individuals is often present. The investigators are doing this research study to improve understanding of whether there is brain and spinal cord atrophy over time that could indicate neurodegeneration. To do this, the investigators will partner with the Cerebral Palsy Research Network to obtain brain and spinal cord MRIs from people with CP across the United States. The investigators will perform analyses on multiple longitudinal MR images of the brain and spinal cord obtained from adults with CP. Putative changes will be related with changes in function across time.

This will be a single-center study that will compare retrospective clinical and imaging data with similar prospective data. The objective is to find out if people with Cerebral Palsy (CP) experience changes in the structures of their brain over time. A key part of the CP definition is that it is a non-progressive brain injury. However, as people with CP age, their function often deteriorates. This study seeks to determine whether changes in the brain structure may result in function changes, as they do in other types of brain injuries.

The investigators are doing this research study to improve understanding of whether there is brain and spinal cord atrophy over time that could indicate neurodegeneration. To do this, the investigators will partner with the Cerebral Palsy Research Network to obtain brain and spinal cord MRIs from people with CP across the United States, as well as locally. The investigators will perform analyses on multiple longitudinal MR images of the brain and spinal cord obtained from adults with CP. Putative changes will be related with changes in function across time.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Weinberg Family Cerebral Palsy Center, Columbia University

New York, 10040, United States

Location status: Recruiting

Location contact

Frank Provenzano, PhD

SUB_INVESTIGATOR

Jason Carmel, MD, PhD

CONTACT

[email protected]

212-305-2700 ext. 3

Jason Carmel, MD, PhD

PRINCIPAL_INVESTIGATOR

Michelle Corkrum, MD, PhD

SUB_INVESTIGATOR

Shaker Dukkipati, MD, PhD

CONTACT

[email protected]

212-305-2700 ext. 3

Shaker Dukkipati, MD, PhD

SUB_INVESTIGATOR

About this study

Cerebral palsy is a neurodevelopmental syndrome that arises during fetal or infant development. Cerebral palsy is defined by a static insult to the brain, such as hypoxia, brain ischemia from stroke or hypotension, infection, or trauma. This brain insult then gives rise to impairment in movement and posture. In developed nations, cerebral palsy accounts for the most common cause of childhood motor disability. Additionally, as medical care advances, survival into adulthood is increasing. Thus, studying the changes associated with cerebral palsy during the aging process is important to providing care to these individuals.

A key part of the cerebral palsy definition is a non-progressive brain injury. However, as people with cerebral palsy age, their function often deteriorates. This study seeks to determine whether changes to brain structure may underlie the functional changes, as they do in other traumatic or ischemic brain injuries. There are established findings of white matter changes, grey matter changes, stroke, and vascular malformation using brain MRI in cerebral palsy, although approximately 13-14% of patients imaged have no injuries visible seen on a clinical MRI brain examination.

These MRI changes are believed to be the representative static lesion(s) that occurred during fetal development or infancy and caused cerebral palsy. The investigators propose that there are structural changes identifiable through MR brain imaging in patients with cerebral palsy over time. Additionally, the clinical and functional worsening seen in cerebral palsy patients as they age may correlate with these MRI changes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Have multiple MRI scans of brain and/or spinal cord spaced at least 24 months apart
  • Between 18-80 years of age with at least one MRI scan after the age of 18
  • No known central or peripheral neurological disease or injury other than cerebral palsy causing brain degeneration
  • Inclusion in CPRN registry
  • diagnosis of Cerebral Palsy
  • >18 years of age
  • Have received at least one past brain MRI scan as part of standard care (patients who have two or more brain MRI scans can be included in the retrospective arm only)

Exclusion criteria

  • History of more than one seizure in lifetime
  • History of known degenerative genetic disorder
  • History of brain tumor, abscess, or multiple sclerosis
  • History of moderate or severe head trauma
  • History of metal implants in head

Treatment and study plan

Primary outcomes

  1. Total brain volume

    Time frame: From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years

    This is a number, measured in cubic millimeters, that includes the output from segmentation of each individual MRI scan per subject.

Secondary outcomes

  1. Cortical thickness

    Time frame: From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years.

    This is a number, measured in millimeters, that includes the output from segmentation of each individual MRI scan per subject. This is calculated as the shortest distance between gray/white matter boundary and the pial surface in both directions, with an average to produce the final thickness value.

Study contacts

Contact information is provided by the study sponsor or research team.

Jason Carmel, MD, PhD

CONTACT

[email protected]

212-305-2700 ext. 3

Shaker Dukkipati, MD, PhD

CONTACT

[email protected]

212-305-2700 ext. 3

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

Evaluation of Brain Changes in Cerebral Palsy Patients

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Feb 25, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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