Cerebral PalsyNCT07433647
Evaluation of Brain MRI Changes in Cerebral Palsy Patients
An observational study of Cerebral Palsy and Spastic Diplegia, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Spastic Diplegia, Spastic Quadriplegia
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 1 Jul 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People with cerebral palsy across the United States
Who may be able to join
- 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
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weinberg Family Cerebral Palsy Center, Columbia University
New York, New York, 10040
Jason Carmel, MD, PhD, 212-305-2700 ext. 3, jbc28@cumc.columbia.edu
Shaker Dukkipati, MD, PhD, 212-305-2700 ext. 3, sd3850@cumc.columbia.edu
About this study
Official title: 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.
Read the 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.
- Keywords
- brain volume, cortical thickness, aging
- Medical subject headings
- Cerebral Palsy, Quadriplegia, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Total brain volume
This is a number, measured in cubic millimeters, that includes the output from segmentation of each individual MRI scan per subject.
Measured: From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years
Secondary outcomes (1)
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.
Measured: From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start20 Jun 2023
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Carmel, Columbia University
- Investigators
- Jason Carmel, MD, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433647
- Sponsor's protocol ID
- AAAU1870
- Status last verified
- May 2026
- First submitted
- 20 Feb 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Brain Changes in Cerebral Palsy Patients
- ClinicalTrials.gov ID
- NCT07433647
- Acronym / sponsor ID
- AAAU1870
- Keywords
- brain volume, cortical thickness, aging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People with cerebral palsy across the United States
Key inclusion criteria (6 listed)
- 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
- diagnosis of Cerebral Palsy
- >18 years of age
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Cortical thickness
Time frame: From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Carmel, MD, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Spastic Diplegia, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Carmel, MD, PhD (212-305-2700 ext. 3, jbc28@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.