Natural History of Cerebral Palsy Prospective Study
Recruiting now
Conditions studied: Cerebral Palsy
In brief
The study will describe the natural history of cerebral palsy (CP) as children develop over the first 2 years of life.
Key facts
- Study ID
- NCT05576948
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 100
- Starts
- 2022-09-08
- Expected to finish
- 2027-09-08
- Last updated by the study team
- 2025-09-25
Who can join
Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants will be included if they have a diagnosis of CP or "at high risk of CP" and under the age of 12 months.
- Infants at high risk of CP as defined by any two (any combination) of the following:
- Neuroimaging predictive of a motor disability including the involvement of 1 or more of the following structures: sensori-motor cortex, Basal Ganglia, Posterior Limb of the Internal Capsule, pyramids.
- Trajectory of cramped synchronized general movements (GMs) on General Movement Assessment (GMA) OR absent fidgety GMs at fidgety age
- Hammersmith Infant Neurological Exam (HINE) scores <57 @ 3months or <60 @ 6months or <63 @9 months
- Infants will also be included if they meet BOTH of the following criteria (even if infants have a HINE score greater than the cut off scores stated above:
- i. Unilateral brain injury on neuroimaging (magnetic resonance imaging (MRI) or cranial ultrasound (CUS)) predictive of CP ii. Clinical signs of asymmetry
You may not qualify if…
- Infants with progressive or neurodegenerative disorders or genetic disorders not associated with CP
- Infants with other disability diagnoses e.g. Down Syndrome
Where it is running
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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