Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02826733
Other study ID # PI08-DR-WALLOIS
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 4, 2009
Est. completion date November 3, 2024

Study information

Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date November 3, 2024
Est. primary completion date November 3, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Days to 10 Weeks
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - 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 .

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Electroencephalogram (EEG)

Near Infra Red Spectroscopy (NIRS)

magnetic resonance imaging (MRI)


Locations

Country Name City State
France CHU Amiens Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT02972853 - Mindful Self-Regulation fMRI Pilot Study N/A
Completed NCT02879565 - Families Expectations and Hope Raised by an Evaluation of Consciousness in Patients in a Vegetative State N/A
Recruiting NCT03893006 - Vehicle Automation Impact on Drivers N/A
Completed NCT03531580 - Comparing Brain Images Before and After MRI-upgrade - TimFit Upgrade Study N/A
Completed NCT02959489 - Risk Evaluation and Education for Alzheimer's Disease - the Study of Communicating Amyloid Neuroimaging (REVEAL-SCAN) N/A
Completed NCT03313674 - Investigation of Seasonal Variations of Brain Structure and Connectivity in SAD N/A
Recruiting NCT05776602 - Fast Brain MRI in Children With Suspected Brain Tumor
Completed NCT05262790 - The Difference of Grey Matter Volume Among the Patients of Schizophrenia
Completed NCT03501004 - The Study of Acupuncture on Vascular and Functional Neuroimaging in Parkinson's Disease Patients With Sleep Disorders N/A
Recruiting NCT05698511 - Neural and Physiological Correlates of Psychedelic Sub-states Phase 1
Not yet recruiting NCT03591315 - Clinical Study of Structural and Functional Evaluation of the Visual Pathway
Recruiting NCT04951700 - Aging and Disease Course: Contributions to Lifespan Neurobiology of Schizophrenia
Not yet recruiting NCT05140850 - Long-term Consequences of Neuroimaging and Perceived Cognitive Dysfunction in oPRES
Withdrawn NCT04671836 - Lorazepam Effects on Neuroimaging Measures Early Phase 1
Completed NCT01514630 - Creatine as a Treatment Option for Depression in Methamphetamine Using Females Phase 4
Completed NCT02939885 - fMRI Study of Brain Mechanisms Related to Emotions N/A
Recruiting NCT04696315 - Early Diagnosis of SCD Based on Radiogenomics
Enrolling by invitation NCT01981148 - Measurement of Retinal Auto Fluorescence With a Fluorescence Lifetime Imaging Ophthalmoscope
Completed NCT03475823 - Cognitive and Blood Flow Effects of Mountain Tea N/A
Completed NCT04135105 - Lexical Tone Perception in Tone language--a fMRI Study