Cerebral Palsy Clinical Trials

Find Cerebral Palsy Clinical Trials Near You

Neuroimaging of Babies During Natural Sleep to Assess Typical Development and Cerebral Palsy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 2 months
Maximum Age: 11 months
Healthy Volunteers: t
View:

⁃ 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.

• 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.

Locations
Other Locations
Denmark
Danish Research Centre for Magnetic Resonance
RECRUITING
Hvidovre
Contact Information
Primary
Line K Johnsen, PhD
linekj@drcmr.dk
+4561145571
Backup
Kathrine Skak Madsen, PhD
kathrine@drcmr.dk
+45 38623323
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 200
Treatments
Typically developing infants
Born after gestational week 37, Uneventful birth, No known history of brain injury, No known neurological disorders
High Risk for Cerebral Palsy
Recruitment through CP-EDIT (Clinical trials.gov ID: NCT05835674), inclusion criteria.~'Newborn-detectable risk-pathway'. Preterm birth with gestational age below 32 or birth weight below 1500 g and clinical concern, Moderate to severe brain injury (Papile grade 3 to 4 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, Extra Corporal Membrane Oxygenation, meningitis, kernicterus, severe hypoglycemia) or neurological risk factors (brain malformation, increased tone), Parental concern and one of the factors above~'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 (as above) or neurological risk factors, Parental concern and one of the factors above.
Related Therapeutic Areas
Sponsors
Leads: Danish Research Centre for Magnetic Resonance
Collaborators: Department of Pediatrics and Adolescent Medicine, Rigshospitalet, Denmark, Hvidovre University Hospital

This content was sourced from clinicaltrials.gov