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Clinical Trial NCT07433647 for Cerebral Palsy, Spastic Diplegia, Spastic Quadriplegia, Spastic Hemiplegia is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Evaluation of Brain MRI Changes in Cerebral Palsy Patients 30
Clinical Trial NCT07433647 is an observational study for Cerebral Palsy, Spastic Diplegia, Spastic Quadriplegia, Spastic Hemiplegia that is recruiting. It started on 20 June 2023 with plans to enroll 30 participants. Led by Columbia University, it is expected to complete by 1 July 2029. The latest data from ClinicalTrials.gov was last updated on 25 February 2026.
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 imp...Show More
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. Additio...Show More
Official Title
Evaluation of Brain Changes in Cerebral Palsy Patients
Conditions
Cerebral PalsySpastic DiplegiaSpastic QuadriplegiaSpastic HemiplegiaOther Study IDs
- AAAU1870
NCT ID Number
Start Date (Actual)
2023-06-20
Last Update Posted
2026-02-25
Completion Date (Estimated)
2029-07-01
Enrollment (Estimated)
30
Study Type
Observational
Status
Recruiting
Keywords
brain volume
cortical thickness
aging
cortical thickness
aging
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Retrospective Patients 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. | N/A |
Prospective Patients 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. | N/A |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Total brain volume | This is a number, measured in cubic millimeters, that includes the output from segmentation of each individual MRI scan per subject. | From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Cortical thickness | 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. | From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
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
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)
- History of more than one seizure in lifetime
- History of known genetic disorder
- History of brain tumor, abscess, or multiple sclerosis
- History of moderate or severe head trauma
- History of metal implants in head
Study Responsible Party
Jason Carmel, Principal Investigator, Weinberg Family Associate Professor of Neurology Chief, Division of Pediatric Neurology, Columbia University
Study Central Contact
Contact: Jason Carmel, MD, PhD, 212-305-2700, [email protected]
Contact: Shaker Dukkipati, MD, PhD, 212-305-2700, [email protected]
1 Study Locations in 1 Countries
New York
Weinberg Family Cerebral Palsy Center, Columbia University, New York, New York, 10040, United States
Jason Carmel, MD, PhD, Contact, 212-305-2700, [email protected]
Shaker Dukkipati, MD, PhD, Contact, 212-305-2700, [email protected]
Jason Carmel, MD, PhD, Principal Investigator
Frank Provenzano, PhD, Sub-Investigator
Shaker Dukkipati, MD, PhD, Sub-Investigator
Michelle Corkrum, MD, PhD, Sub-Investigator
Recruiting