Menu
Recruiting NCT07433647

Evaluation of Brain MRI Changes in Cerebral Palsy Patients

Observational Cerebral Palsy Spastic Diplegia Spastic Quadriplegia Spastic Hemiplegia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cerebral Palsy, Spastic Diplegia, Spastic Quadriplegia, Spastic Hemiplegia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation of Brain Changes in Cerebral Palsy Patients

Overview

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.

Detailed description

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.

Primary outcome measures

  • Total brain volume [Time frame: From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years]
Secondary outcome measures (1)
  • Cortical thickness [Time frame: From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Weinberg Family Cerebral Palsy Center, Columbia University — New York

Identifiers

NCT: NCT07433647 · AAAU1870

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗