Healthy VolunteersLaBRhythmsNCT04457622
Language and Brain Rhythms
A study testing Auditory perception tasks in healthy participants in people with Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
For humans and other animals, predicting the timing of sensory events is essential for their daily behavior. Importantly, natural sensory stimulation (such as movements, music, or speech) can present temporal regularities allowing for temporal prediction of incoming sensory information. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Auditory perception tasks in healthy participants
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 1 siteFrance
- Study dates
- 18 Feb 2021to 16 Mar 2026
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For all experiments:
- 18- 40 years old
- Registration with the French healthcare system
- Informed consent
- Normal hearing
- Additionally, for experiments 2,3 and 4 :
Show all 9Show fewer
- Right handed
- Additionally, for experiment 3 and 4:
- French as native language
Who cannot join
- For All Experiments:
- Neurological or psychiatric illnesses or a history of such problems that could impact quality/variability of data or cooperation and retention of the subject in the study
- Regular use of medications that impact the central nervous system
- Regular use of medications, such as opioids and antidepressants, including SSRIs and tricyclic antidepressants
- Severe hearing loss
- A history of stroke or recent trauma to the head
Show all 19Show fewer
- Persons unable to adhere to abstinence from the use of drugs or alcohol the day or evening before experimental sessions
- Women who are pregnant, breastfeeding, or have given birth in the last 6 months
- Additionally, for experiment 2,3 and 4 :
- A pacemaker, insulin or other pump, neurostimulator, cochlear implants or other hearing aid, metal stents, prosthesis, or implants, intracerebral clips, implantable defibrillator, cerebral shunt or ventricular catheter, other foreign metal objects in the upper part of the body
- any dental apparatus containing metal including or root canals
- any foreign metallic object anywhere in the body
- bolts, screws
- orthopedic devices or implants
- Additionally, for experiment 3 and 4:
- claustrophobia
- glasses (given the participant cannot use contact lenses)
- a head size incompatible with the use of a personalized 3D headcast or a magnetoencephalography
- Persons having had any surgery prior to the study which puts them at risk for metal objects left in the body
Trial locations and contacts
1 site in 1 country.
About this study
For humans and other animals, predicting the timing of sensory events is essential for their daily behavior. Importantly, natural sensory stimulation (such as movements, music, or speech) can present temporal regularities allowing for temporal prediction of incoming sensory information. For instance, individuals can easily predict in time the next step of a walker, or the next beat of a song based on the rhythm. The phenomenon of temporal prediction has for now only been investigated experimentally in deterministic scenarios, i.e. when the duration between two sensory events is fixed, or when stimuli present a regular beat. The objective of this project is to understand how we process more natural, hence more complex forms of temporal regularities, and how individuals make inferences on the timing of sensory events based on past temporal statistics of sensory information. This is particularly important for speech processing, considering that speech is an acoustic signal that is known to possess some form of temporal regularity, and yet is not purely rhythmic nor does have a deterministic temporal structure. Temporal regularities are specific to each spoken language, and both native and non-native language listeners are known to use temporal acoustic cues during speech listening. This affects speech comprehension and has a strong impact during language learning. Hence, understanding the processing of temporal regularities in speech can help improve language abilities in first and second language learners.
The project is composed of four experiments. The first behavioral experiment will investigate how auditory perception is affected by the temporal statistics of past sensory information using artificial stimuli. The second axis will investigate the neural mechanisms underlying auditory timing processing with electroencephalography (EEG). The last Magnetoencephalography (MEG, experiment 3) and EG (rxperiement 4) experiment will test the role of temporal statistics in an ecological setting, namely speech listening. The project will thus provide strong theoretical advances as it will give new insights on brain mechanisms for the processing of complex temporal information in audition and speech, and their role in language comprehension. It will also provide methodological advances. Specifically, the project will contribute to the development and validation of cutting-edge methods in MEG. Namely, it will aim at creating new tools to investigate the neural correlates of auditory and speech processing with an unprecedented temporal and spatial resolution.
- Conditions
- Healthy Volunteers
- Being tested
- Auditory perception tasks in healthy participants
- Keywords
- Auditory Perception, Speech, Neuroimaging
- Medical subject headings
- Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory perception tasks in healthy participantsOther
The participants complete auditory perception tasks while EEG, and MEG record brain signals (primary outcome measure). The tasks acquire behavioral responses with button presses (secondary outcome measure).
All analyses are intra-subject (no analyses are between-subject).
| Study group | Role | What they receive |
|---|---|---|
| Main study group | Experimental | All participants signed up for experiment 1, 2, 3 or 4 complete the same protocol (1 study arm) with an intent for intra-subject correlational analyses Receives: Other: Auditory perception tasks in healthy participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulus-Brain (EEG) Coherence in the delta-theta range (1 Hz - 8 Hz)
Measured: at max 90 days
Amplitude of EEG evoked responses to the target stimuli
Measured: at max 90 days
Stimulus-Brain (MEG) Coherence in the delta-theta range (1 Hz - 8 Hz)
Measured: at max 90 days
Amplitude of MEG evoked responses to the target stimuli
Measured: at max 90 days
Secondary outcomes (2)
Percentage of correct responses
The secondary outcome measures will be recorded in all experiments
Measured: at max 90 days
Response Times
The secondary outcome measures will be recorded in all experiments
Measured: at max 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start18 Feb 2021
- Primary completion16 Mar 2026
- Study completion16 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne KOSEM, PhD, Principal investigator, Centre de recherche de Neurosciences de Lyon (CRNL)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457622
- Sponsor's protocol ID
- 69HCL20_0333
- Other IDs
- 2020-A01231-38
- Acronym
- LaBRhythms
- Status last verified
- Aug 2026
- First submitted
- 12 Jun 2020
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Language and Brain Rhythms
- ClinicalTrials.gov ID
- NCT04457622
- Acronym / sponsor ID
- LaBRhythms / 69HCL20_0333
- Conditions
- Healthy Volunteers
- Keywords
- Auditory Perception, Speech, Neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 18 Feb 2021 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 16 Mar 2026 (actual)
- First posted
- 7 Jul 2020 (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.
For humans and other animals, predicting the timing of sensory events is essential for their daily behavior. Importantly, natural sensory stimulation (such as movements, music, or speech) can present temporal regularities allowing for temporal prediction of incoming sensory information. For instance, individuals can easily predict in time the next step of a walker, or the next beat of a song based on the rhythm. The phenomenon of temporal prediction has for now only been investigated experimentally in deterministic scenarios, i.e. when the duration between two sensory events is fixed, or when stimuli present a regular beat. The objective of this project is to understand how we process more natural, hence more complex forms of temporal regularities, and how individuals make inferences on the timing of sensory events based on past temporal statistics of sensory information. This is particularly important for speech processing, considering that speech is an acoustic signal that is known to possess some form of temporal regularity, and yet is not purely rhythmic nor does have a deterministic temporal structure. Temporal regularities are specific to each spoken language, and both native and non-native language listeners are known to use temporal acoustic cues during speech listening. This affects speech comprehension and has a strong impact during language learning. Hence, understanding the processing of temporal regularities in speech can help improve language abilities in first and second language learners.
The project is composed of four experiments. The first behavioral experiment will investigate how auditory perception is affected by the temporal statistics of past sensory information using artificial stimuli. The second axis will investigate the neural mechanisms underlying auditory timing processing with electroencephalography (EEG). The last Magnetoencephalography (MEG, experiment 3) and EG (rxperiement 4) experiment will test the role of temporal statistics in an ecological setting, namely speech listening. The project will thus provide strong theoretical advances as it will give new insights on brain mechanisms for the processing of complex temporal information in audition and speech, and their role in language comprehension. It will also provide methodological advances. Specifically, the project will contribute to the development and validation of cutting-edge methods in MEG. Namely, it will aim at creating new tools to investigate the neural correlates of auditory and speech processing with an unprecedented temporal and spatial resolution.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main study group | Experimental | Other: Auditory perception tasks in healthy participantsAll participants signed up for experiment 1, 2, 3 or 4 complete the same protocol (1 study arm) with an intent for intra-subject correlational analyses |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 18- 40 years old
- Registration with the French healthcare system
- Informed consent
- Normal hearing
- Right handed
Key exclusion criteria (19 listed)
- Neurological or psychiatric illnesses or a history of such problems that could impact quality/variability of data or cooperation and retention of the subject in the study
- Regular use of medications that impact the central nervous system
- Regular use of medications, such as opioids and antidepressants, including SSRIs and tricyclic antidepressants
- Severe hearing loss
- A history of stroke or recent trauma to the head
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 |
|---|---|---|
| Auditory perception tasks in healthy participantsThe participants complete auditory perception tasks while EEG, and MEG record brain signals (primary outcome measure). The tasks acquire behavioral responses with button presses (secondary outcome measure). All analyses are intra-subject (no analyses are between-subject). | Other | Main study group |
Primary outcome
Stimulus-Brain (EEG) Coherence in the delta-theta range (1 Hz - 8 Hz)
Time frame: at max 90 days
Amplitude of EEG evoked responses to the target stimuli
Time frame: at max 90 days
Stimulus-Brain (MEG) Coherence in the delta-theta range (1 Hz - 8 Hz)
Time frame: at max 90 days
Amplitude of MEG evoked responses to the target stimuli
Time frame: at max 90 days
2 secondary outcomes
Percentage of correct responses
Time frame: at max 90 days
Response Times
Time frame: at max 90 days
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 20 Aug 2026.
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingPhase 1
First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers
Healthy
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.
Anne KOSEM, PhD principal investigator
Centre de recherche de Neurosciences de Lyon (CRNL)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory perception tasks in healthy participants in people with Healthy Volunteers, run by Hospices Civils de Lyon 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 9 inclusion and 19 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 20 Aug 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?
Stimulus-Brain (EEG) Coherence in the delta-theta range (1 Hz - 8 Hz) (time frame: at max 90 days). The study lists 4 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 20 Aug 2026.