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Study identifier: NCT06396520 Synced from ClinicalTrials.gov · July 28, 2026
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Neuroimaging of Babies During Natural Sleep to Assess Typical Development and Cerebral Palsy

Condition: Cerebral Palsy · Infant Development · Development, Infant  ·  Sponsor: Danish Research Centre for Magnetic Resonance

PhaseN/A
Planned participants200
Who can joinAll sexes, 2 Months to 11 Months
Healthy volunteersYes

About this study

Background: Early diagnosis of cerebral palsy (CP) is crucial, enabling intervention when neuroplasticity is at its highest. Magnetic resonance imaging (MRI) plays a vital role in CP diagnosis. Currently, diagnostic MRI of newborns and infants with suspected brain damage relies heavily on structural MR images. The current study aims to i) establish procedures for clinical infant and toddler MRI during natural sleep, ii) use advanced MRI sequences, such as advanced diffusion-weighted imaging (DWI), that may be more sensitive in detecting early brain damage, and iii) map relationships between early brain development, and motor function and development. Methods: The NIBS-CP study will enroll approximately 200 infants either at risk for CP or typically developing. Infants will be followed longitudinally (for three waves) between 3 months and 2 years of age with cerebral MRI at 3 Tesla and comprehensive assessments of motor and cognitive functioning. The MRI protocol includes advanced diffusion-weighted imaging, high-resolution structural MRI, and MR spectroscopy. The motor and cognitive assessments include Hand Assessment in Infants, Alberta Infant Motor Scales, Hammersmith Infant Neurological Examination, Peabody Developmental Motor Scales, Bayley Scales of Infant Development, and Ages and Stages Questionnaires. NIBS-CP aims to establish normative material on early brain development of Danish children and conduct normative modeling of typical and atypical development to identif…

This description comes directly from the study's public registry record.

Talk to the study team

Line K Johnsen, PhD  ·  +4561145571  ·  linekj@drcmr.dk

Kathrine Skak Madsen, PhD  ·  +45 38623323  ·  kathrine@drcmr.dk

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Locations (1)

Danish Research Centre for Magnetic ResonanceHvidovre, Capital Region, DenmarkRecruiting

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Source record: clinicaltrials.gov/study/NCT06396520