- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07433647
Evaluation of Brain MRI Changes in Cerebral Palsy Patients
Evaluation of Brain 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.
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jason Carmel, MD, PhD
- Phone Number: 3 212-305-2700
- Email: jbc28@cumc.columbia.edu
Study Contact Backup
- Name: Shaker Dukkipati, MD, PhD
- Phone Number: 3 212-305-2700
- Email: sd3850@cumc.columbia.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10040
- Recruiting
- Weinberg Family Cerebral Palsy Center, Columbia University
-
Contact:
- Jason Carmel, MD, PhD
- Phone Number: 3 212-305-2700
- Email: jbc28@cumc.columbia.edu
-
Contact:
- Shaker Dukkipati, MD, PhD
- Phone Number: 3 212-305-2700
- Email: sd3850@cumc.columbia.edu
-
Principal Investigator:
- Jason Carmel, MD, PhD
-
Sub-Investigator:
- Frank Provenzano, PhD
-
Sub-Investigator:
- Shaker Dukkipati, MD, PhD
-
Sub-Investigator:
- Michelle Corkrum, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jason Carmel, MD, PhD, Columbia University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAU1870
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Ankara City Hospital BilkentRecruitingCerebral Palsy (CP) | Cerebral Palsy, Spastic, Diplegic | Diplegic Cerebral Palsy With Spasticity | Transcranial Magnetic StimilationTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesRecruiting
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Holland Bloorview Kids Rehabilitation HospitalCanadian Institutes of Health Research (CIHR)RecruitingCerebral Palsy (CP) | Hemiplegic Cerebral PalsyCanada
-
Cairo UniversityCompletedCerebral Palsy (CP) | Unilateral Cerebral PalsyEgypt
-
University of California, San FranciscoNot yet recruitingCerebral Palsy | Cerebral Palsy (CP) | Infant | Cerebral Palsy InfantileUnited States
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
IRCCS Fondazione Stella MarisNot yet recruitingCerebral Palsy (CP) | EEG | Unilateral Cerebral Palsy | Action ObservationItaly
-
IRCCS Fondazione Stella MarisUniversity of Siena, ItalyRecruitingCerebral Palsy (CP) | Motor Imagery | CP (Cerebral Palsy) | Action ObservationItaly
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey