Sleeping baby MRI could unlock early cerebral palsy diagnosis
NCT ID NCT06396520
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study uses MRI scans of babies during natural sleep to understand how the brain develops in both healthy infants and those at risk for cerebral palsy. Researchers will follow about 200 infants from 3 months to 2 years old, using advanced imaging and motor skill tests. The goal is to find early brain signs that predict cerebral palsy, allowing for earlier treatment when it can have the most impact.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to earlier and more accurate diagnosis of cerebral palsy in infants, enabling timely interventions when the brain is most adaptable.
- What could go wrong
- This is an observational study, not a treatment trial. It may not directly change clinical practice, and the advanced MRI techniques might not prove more effective than current methods.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Infants at risk of cerebral palsy: 160 infants with a high risk of CP will be enrolled in CP-EDIT (ClinicalTrials.gov ID NCT05835674). At least 2/3 are expected to be from the 'new-born detectable risk pathway' and less than 1/3 from the 'infant-detectable pathway'. At inclusion, infants will mainly be 3-6 months of age, though the age range between 2-11 months is accepted. It is expected that at least 50-60 of the high-risk infants will participate in the NIBS-CP study, with an upper limit of 100 infants. Typically developing infants: To establish a Danish normative sample of early brain development and a control group to the CP-EDIT cohort, approx. 140-150 typically developing infants will be recruited to NIBS-CP (approx. 200 infants when combining the high-risk and typically developing groups). The age range and mean age of the typically developing infants will be matched to that of the high-risk infants.
- Ages
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2 to 11 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria High-Risk population: Group: 'Newborn-detectable risk-pathway' * Preterm birth with gestational age below 32 weeks * Birth weight below 1500 g * Moderate to severe brain injury (A label of moderate to severe brain injury was considered if there was Papile grade three to four intraventricular haemorrhage, cystic periventricular leukomalacia, neonatal stroke, term hypoxic-ischaemic encephalopathy (≥35 weeks gestation at birth) or other significant neurological condition) * History (e.g., neonatal seizures, ECMO, meningitis, kernicterus, severe hypoglycemia) or neurological risk factors (malformations in CNS, increased tone) Group: 'Infant detectable risk-pathway' * Inability to sit independently by age 9 months * Hand function asymmetry or crawl asymmetry * Inability to take weight through the plantar surface of the feet * History (e.g., as above) or neurological risk factors Additional inclusion criteria for inclusion in NIBS-CP for both CP-risk groups: \- Consent to health-relevant information on clinical findings being passed on to the medical doctors in CP-EDIT and/or their primary care physician. Inclusion Criteria Typically developing infant population: * Born \>37 weeks * Uneventful birth * No known history of brain injury * No neurological condition * Consent to health-relevant information on clinical findings being passed on to their primary care physician or relevant medical doctors, e.g., neuropaediatrician. Exclusion Criteria (all groups): * Infants have any MRI contraindications, e.g., pacemaker or other implanted electronic devices. * Families do not speak or understand Danish. * Families do not wish to be informed about incidental findings on the MRI, or scores within the clinical range in the neurological, motor, or cognitive assessments.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Danish Research Centre for Magnetic Resonance
RECRUITINGHvidovre, Capital Region, 2650, Denmark
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Other studies related to the condition(s) this trial covers.
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