Evaluation of the Implementation of the Hemispheric Dominance During Development

NCT02826733 | Unknown

• 1 other identifier: PI08-DR-WALLOIS
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Many cognitive functions in human are based on asymmetric brain networks. For most adults, language is processed largely by the left hemisphere while other auditory treatments, such as voice recognition are rather based on the right hemisphere. Many studies helped to highlight the presence of anatomical and functional asymmetries both in the first months of life. What are the causes of these imbalances? How do they develop? Are they necessary for operation or for effective learning? The investigators would like in this work, in collaboration with applied mathematics team of Compiègne and INSERM team, to determine from which period the development of hemispheric dominance is set up for recognition of language and in which brain structure it occurs in preterm infants whose sound environment is usually very different from that of the fetus. The impact of this environment on brain development of infants and their early learning will be assessed.

Conditions

Neuroimaging

Keywords

preterm infants; term infants; hemispheric dominance

Outcome Measures

Primary Outcomes (2)

• discrimination of language - EEG

  Determine at what developmental age the newborn and premature are able to discriminate language based on the results of evoked potentials obtained from the EEG signals

  Day 0

• discrimination of language - NIRS

  Determine at what developmental age the newborn and premature are able to discriminate language based on the results of evoked potentials obtained from the NIRS signals

  Day 0

Study Arms (2)

Normal

Every child meet the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF , Scanner, MRI). EEG NIRS MRI

Device: Electroencephalogram (EEG); Device: Near Infra Red Spectroscopy (NIRS); Device: magnetic resonance imaging (MRI)

cerebral neurological disease

Group of children meeting the criteria of age and having a detectable neurological disease after clinical, neurophysiological and radiological (ETF , Scanner, MRI) The children present either convulsions or a cerebrovascular accident or a neurological pain . Each condition being verified by a pathological electroencephalogram . EEG NIRS MRI

Device: Electroencephalogram (EEG); Device: Near Infra Red Spectroscopy (NIRS); Device: magnetic resonance imaging (MRI)

Interventions

Electroencephalogram (EEG) DEVICE

Normal; cerebral neurological disease

Near Infra Red Spectroscopy (NIRS) DEVICE

Normal; cerebral neurological disease

magnetic resonance imaging (MRI) DEVICE

Normal; cerebral neurological disease

Eligibility Criteria

• Age: 0 Days - 10 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The inclusion of patients in the study will be conducted in the intensive care unit and neonatal intensive care CHU Amiens .

You may qualify if:

• preterm gestational age over 26 weeks of gestation + 6 days and less than 42 weeks.
• normal group of children : A child meets the age criteria and without ductus arteriosus persistence ultrasound or detectable neurological disorders after clinical, neurophysiological and radiological (ETF , Scanner, MRI).
• Group of children meet the age criteria and with cerebral neurological pathology detectable after clinical, neurophysiological and radiological (ETF , Scanner, MRI).

You may not qualify if:

• severe congenital malformation
• Any refusal of a parent .
• Children with severe impairment of the general condition and vital functions
• Children with dermatitis of the face or scalp
• Children treated with ventilation High Frequency (HFO )
• Presence of intravenous access on the scalp ( preventing the realization of the ETF , EEG or NIRS .

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Interventions

Electroencephalography; Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Tomography; Diagnostic Imaging

Study Officials

• Fabrice WALLOIS, MD, PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2016
• First Posted: July 11, 2016
• Study Start: November 4, 2009
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

FR (1)