NeuroimagingHEMISPHERENORNCT02826733
Evaluation of the Implementation of the Hemispheric Dominance During Development
An observational study of Neuroimaging, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 0 days to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Neuroimaging
- What is being tested?
- Electroencephalogram (EEG), Near Infra Red Spectroscopy (NIRS) and magnetic resonance imaging (MRI)
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 4 Nov 2009to 8 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: The inclusion of patients in the study will be conducted in the intensive care unit and neonatal intensive care CHU Amiens .
Who may be able to join
- 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).
Who cannot join
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Implementation of the Hemispheric Dominance During Development : Electrometabolic and Hemodynamics Study in the Newborn Born Premature or Term
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
- Being tested
- Electroencephalogram (EEG), Near Infra Red Spectroscopy (NIRS), magnetic resonance imaging (MRI)
- Keywords
- preterm infants, term infants, hemispheric dominance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electroencephalogram (EEG)Device
Near Infra Red Spectroscopy (NIRS)Device
magnetic resonance imaging (MRI)Device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Electroencephalogram (EEG); Device: Near Infra Red Spectroscopy (NIRS); Device: magnetic resonance imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start4 Nov 2009
- Primary completion8 Feb 2024
- Study completion8 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroimagingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice WALLOIS, MD, PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826733
- Sponsor's protocol ID
- PI08-DR-WALLOIS
- Acronym
- HEMISPHERENOR
- Status last verified
- Jun 2026
- First submitted
- 5 Jul 2016
- Last updated
- 12 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Implementation of the Hemispheric Dominance During Development : Electrometabolic and Hemodynamics Study in the Newborn Born Premature or Term
- ClinicalTrials.gov ID
- NCT02826733
- Acronym / sponsor ID
- HEMISPHERENOR / PI08-DR-WALLOIS
- Conditions
- Neuroimaging
- Keywords
- preterm infants, term infants, hemispheric dominance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 4 Nov 2009 (actual)
- Primary completion
- 8 Feb 2024 (actual)
- Study completion
- 8 Feb 2024 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal | – | Device: Electroencephalogram (EEG), Device: Near Infra Red Spectroscopy (NIRS), Device: magnetic resonance imaging (MRI)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 |
| cerebral neurological disease | – | Device: Electroencephalogram (EEG), Device: Near Infra Red Spectroscopy (NIRS), Device: magnetic resonance imaging (MRI)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 |
Who may qualify
- Ages
- 0 days to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The inclusion of patients in the study will be conducted in the intensive care unit and neonatal intensive care CHU Amiens .
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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 )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
discrimination of language - EEG
Time frame: Day 0
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
discrimination of language - NIRS
Time frame: Day 0
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice WALLOIS, MD, PhD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroimaging, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
discrimination of language - EEG (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.