Time PerceptionExpositionNCT05417542
Multimodal Analysis of the Young Brain on Rhythm Perception: From Premature Neonates to Infants
A study testing EEG and NIRS in people with Time Perception and Rhythm, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Premature neonates are able to discriminate phonemes and voice from 28wGA at a time the neuronal network establish contact between the environment and the cortical neurones. In the present monocentric study the investigators will analyse the response of the cortical network in premature aged between 28 and 40 wGA in… Read more about this study
- Who is it for?
- Ages 0 days to 18 years
- Conditions the study is for
- Time Perception, Rhythm, EEG
- What is being tested?
- EEG and NIRS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2022to May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Full term neonates between 28 and 40 weeks Gestational Age
Who cannot join
- Neonates outside the age range
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80054
Fabrice WALLOIS, MD, PhD, +33 3 22 08 77 77, wallois.fabrice@chu-amiens.fr
About this study
Premature neonates are able to discriminate phonemes and voice from 28wGA at a time the neuronal network establish contact between the environment and the cortical neurones. In the present monocentric study the investigators will analyse the response of the cortical network in premature aged between 28 and 40 wGA in response to auditory stimuli using High Resolution Electroencephalography and High Density Near Infrared Spectroscopy
- Conditions
- Time Perception, Rhythm, EEG, fNIRS, ERP, Premature Neonates
- Being tested
- EEG, NIRS
- Keywords
- Time perception, rhythm, EEG, fNIRS, ERP, Premature neonates, Discrimination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGOther
EEG recording during prematurity or around term
NIRSOther
NIRS recording during prematurity or around term
| Study group | Role | What they receive |
|---|---|---|
| Exposition I | Experimental | preterm neonates between 28 and 30 wGA Exposition to music during the NICU period Receives: Other: EEG; Other: NIRS |
| Exposition II | Experimental | preterm neonates between 32 and 34 wGA Exposition to music during the NICU period Receives: Other: EEG; Other: NIRS |
| Control I | Active comparator | preterm neonates between 28 and 30 wGA Receives: Other: EEG; Other: NIRS |
| Control II | Active comparator | preterm neonates between 32 and 34 wGA Receives: Other: EEG; Other: NIRS |
| Control III | Active comparator | preterm neonates between 36 and 40 wGA Receives: Other: EEG; Other: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variations of the response of the cortical network using High Resolution Electroencephalography before auditory stimuli between the 5 infant groups
Measured: one day
Variations of the response of the cortical network using High Resolution Electroencephalography during auditory stimuli between the 5 infant groups
Measured: one day
Variations of the response of the cortical network using High Resolution Electroencephalography after auditory stimuli between the 5 infant groups
Measured: one day
variations of the response of the cortical network using High Density Near Infrared Spectroscopy before auditory stimuli between the 5 infant groups
Measured: one day
variations of the response of the cortical network using High Density Near Infrared Spectroscopy during auditory stimuli between the 5 infant groups
Measured: one day
variations of the response of the cortical network using High Density Near Infrared Spectroscopy after auditory stimuli between the 5 infant groups
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start31 May 2022
- Primary completionMay 2029 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Time PerceptionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417542
- Sponsor's protocol ID
- PI2021_843_0054
- Acronym
- Exposition
- Status last verified
- May 2025
- First submitted
- 31 May 2022
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Analysis of the Young Brain on Rhythm Perception: From Premature Neonates to Infants
- ClinicalTrials.gov ID
- NCT05417542
- Acronym / sponsor ID
- Exposition / PI2021_843_0054
- Conditions
- Time Perception, Rhythm, EEG, fNIRS, ERP, Premature Neonates
- Keywords
- Time perception, rhythm, EEG, fNIRS, ERP, Premature neonates, Discrimination
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 14 Jun 2022 (actual)
- 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.
Premature neonates are able to discriminate phonemes and voice from 28wGA at a time the neuronal network establish contact between the environment and the cortical neurones. In the present monocentric study the investigators will analyse the response of the cortical network in premature aged between 28 and 40 wGA in response to auditory stimuli using High Resolution Electroencephalography and High Density Near Infrared Spectroscopy
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Exposition I | Experimental | Other: EEG, Other: NIRSpreterm neonates between 28 and 30 wGA Exposition to music during the NICU period |
| Exposition II | Experimental | Other: EEG, Other: NIRSpreterm neonates between 32 and 34 wGA Exposition to music during the NICU period |
| Control I | Active comparator | Other: EEG, Other: NIRSpreterm neonates between 28 and 30 wGA |
| Control II | Active comparator | Other: EEG, Other: NIRSpreterm neonates between 32 and 34 wGA |
| Control III | Active comparator | Other: EEG, Other: NIRSpreterm neonates between 36 and 40 wGA |
Who may qualify
- Ages
- 0 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Full term neonates between 28 and 40 weeks Gestational Age
Key exclusion criteria (1 listed)
- Neonates outside the age range
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 |
|---|---|---|
| EEGEEG recording during prematurity or around term | Other | Control I, Control II, Control III, Exposition I, Exposition II |
| NIRSNIRS recording during prematurity or around term | Other | Control I, Control II, Control III, Exposition I, Exposition II |
Primary outcome
Variations of the response of the cortical network using High Resolution Electroencephalography before auditory stimuli between the 5 infant groups
Time frame: one day
Variations of the response of the cortical network using High Resolution Electroencephalography during auditory stimuli between the 5 infant groups
Time frame: one day
Variations of the response of the cortical network using High Resolution Electroencephalography after auditory stimuli between the 5 infant groups
Time frame: one day
variations of the response of the cortical network using High Density Near Infrared Spectroscopy before auditory stimuli between the 5 infant groups
Time frame: one day
variations of the response of the cortical network using High Density Near Infrared Spectroscopy during auditory stimuli between the 5 infant groups
Time frame: one day
variations of the response of the cortical network using High Density Near Infrared Spectroscopy after auditory stimuli between the 5 infant groups
Time frame: one day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EEG and NIRS in people with Time Perception and Rhythm, 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 28 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrice Wallois, Pr (03 22 087775, fabrice.wallois@u-picardie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variations of the response of the cortical network using High Resolution Electroencephalography before auditory stimuli between the 5 infant groups (time frame: one day). The study lists 6 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 28 May 2025.