NCT07433647

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
38mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress48%
Jun 2023Jul 2029

Study Start

First participant enrolled

June 20, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2026

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

February 20, 2026

Last Update Submit

February 20, 2026

Conditions

Keywords

brain volumecortical thicknessaging

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Cortical thickness

    From first MRI scan to second MRI scan, composed of a timespan of at least 2 or more years.

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People with cerebral palsy across the United States

You may qualify if:

  • 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
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weinberg Family Cerebral Palsy Center, Columbia University

New York, New York, 10040, United States

RECRUITING

MeSH Terms

Conditions

Cerebral PalsyQuadriplegiaHemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jason Carmel, MD, PhD

    Columbia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Carmel, MD, PhD

CONTACT

Shaker Dukkipati, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Weinberg Family Associate Professor of Neurology Chief, Division of Pediatric Neurology

Study Record Dates

First Submitted

February 20, 2026

First Posted

February 25, 2026

Study Start

June 20, 2023

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2029

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations