NCT06396520 Neuroimaging of Babies During Natural Sleep to Assess Typical Development and Cerebral Palsy
| NCT ID | NCT06396520 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Danish Research Centre for Magnetic Resonance |
| Condition | Cerebral Palsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-06-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 identify deviations in brain development at the level of the single child. Discussion: Identifying predictive brain structural features of motor function and motor development is key to the future use of early MRI in the clinical work-up, as this promotes early diagnosis and (clinical) intervention strategies tailored to the individual child.
Eligibility Criteria
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.
Contact & Investigator
Kathrine Skak Madsen, PhD
PRINCIPAL INVESTIGATOR
Senior Researcher
Frequently Asked Questions
Who can join the NCT06396520 clinical trial?
This trial is open to participants of all sexes, aged 2 Months or older, up to 11 Months, studying Cerebral Palsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06396520 currently recruiting?
Yes, NCT06396520 is actively recruiting participants. Contact the research team at linekj@drcmr.dk for enrollment information.
Where is the NCT06396520 trial being conducted?
This trial is being conducted at Hvidovre, Denmark.
Who is sponsoring the NCT06396520 clinical trial?
NCT06396520 is sponsored by Danish Research Centre for Magnetic Resonance. The principal investigator is Kathrine Skak Madsen, PhD at Senior Researcher. The trial plans to enroll 200 participants.
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