Evaluation of Brain MRI Changes in Cerebral Palsy Patients
Part of paid clinical trials in New York, New York.
- Sponsor
- Columbia University
- Study ID
- NCT07433647
- Status
- Recruiting
Conditions
- Cerebral Palsy
- Spastic Diplegia
- Spastic Hemiplegia
- Spastic Quadriplegia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 80 Years
- Healthy Volunteers
- Accepted
Study Details
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.
Key Dates
- Start date
- Jun 20, 2023
- Status verified
- May 2026
- Primary completion
- Jul 1, 2028
- Completion
- Jul 1, 2029
Study Design
- Enrollment
- 30 participants (estimated)
Arms
- Arm: RetrospectivePatients who have a diagnosis of cerebral palsy, are adults (\>18 years of age), and have at least one brain MRI will be identified through chart review. Those patients who have two or more brain MRI scans will be included in the retrospective arm only.
- Arm: ProspectivePatients who have only one brain MRI scan will be included in the prospective arm of the study. These patients will undergo MRIs of both the brain and cervical spine without contrast.
Primary Outcome Measure
Total brain volume [ Time Frame: From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years ]
Central Contacts
- Jason Carmel, MD, PhD212-305-2700
- Shaker Dukkipati, MD, PhD212-305-2700
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Weinberg Family Cerebral Palsy Center, Columbia University | New York | New York | 10040 | Jason Carmel, MD, PhD (PRINCIPAL_INVESTIGATOR) Frank Provenzano, PhD (SUB_INVESTIGATOR) Shaker Dukkipati, MD, PhD (SUB_INVESTIGATOR) Michelle Corkrum, MD, PhD (SUB_INVESTIGATOR) |
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