NCT07433647 Evaluation of Brain MRI Changes in Cerebral Palsy Patients
| NCT ID | NCT07433647 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Cerebral Palsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-06-20 |
| Primary Completion | 2028-07-01 |
Eligibility & Interventions
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2023-06-20 with a primary completion date of 2028-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Jason Carmel, MD, PhD
PRINCIPAL INVESTIGATOR
Columbia University
Frequently Asked Questions
Who can join the NCT07433647 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07433647 currently recruiting?
Yes, NCT07433647 is actively recruiting participants. Contact the research team at jbc28@cumc.columbia.edu for enrollment information.
Where is the NCT07433647 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07433647 clinical trial?
NCT07433647 is sponsored by Columbia University. The principal investigator is Jason Carmel, MD, PhD at Columbia University. The trial plans to enroll 30 participants.
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