Autism Spectrum DisorderTHETABOOSTNCT07303413
A Rhythmic and Auditory Approach for Children With Autism Spectrum Disorders (ASD)
A study testing EEG recording and Picture recognition test in people with Autism Spectrum Disorder, run by Institut Pasteur.
Trial summary
The aim of this study is to assess the effectiveness of a rhythmic auditory training program in improving language skills in children with Autism Spectrum Disorder (ASD) who have a language acquisition disorder. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- EEG recording and Picture recognition test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Sep 2027
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- aged between 3 and 6 at the time of inclusion
- Have received a formal medical diagnosis of ASD
- Have the consent of the parent(s)
- Declaration of a language delay by the parents
- Affiliated to social security or equivalent scheme
Who cannot join
- Conditions likely to interfere with the EEG and make its interpretation difficult, including severe epilepsy or cerebral malformations.
- Treatments likely to interfere with the EEG (sedatives, psychostimulants, anxiolytics, antidepressants).
- Known hearing impairment
About this study
Official title: Approche Rythmique et Auditive Chez Les Enfants Avec Troubles du Spectre de l'Autisme (TSA)
The aim of this study is to assess the effectiveness of a rhythmic auditory training program in improving language skills in children with Autism Spectrum Disorder (ASD) who have a language acquisition disorder. The program focuses on training children to reproduce the syllable rhythms of speech, and the study will evaluate the children's language skills before and after participating in the program.
- Conditions
- Autism Spectrum Disorder
- Being tested
- EEG recording, Picture recognition test
- Keywords
- language
- Medical subject headings
- Autism Spectrum Disorder, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG recordingBehavioural
EEG recording while listening to natural sounds
Picture recognition testBehavioural
Children will have 4 images in front of them and a sound recording will be played to tell them which image to choose. They will have to click on the one that corresponds to what was said in the sound recording.
| Study group | Role | What they receive |
|---|---|---|
| short baseline | Experimental | First baseline of 4 weeks and a second baseline of 8 weeks Receives: Behavioral: EEG recording; Behavioral: Picture recognition test |
| medium baseline | Experimental | First baseline of 6 weeks and a second baseline of 6 weeks Receives: Behavioral: EEG recording; Behavioral: Picture recognition test |
| long baseline | Experimental | First baseline of 8 weeks and a second baseline of 4 weeks Receives: Behavioral: EEG recording; Behavioral: Picture recognition test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the progression of language acquisition measured by the difference in the number of images recognised in image recognition tests.
Measured: 12 weeks
Secondary outcomes (12)
Comparison of Neural tracking of speech via EEG measurements of brain oscillatory activity before and after a session of listening to rhythmic sound.
Measured: 12 weeks
Comparison of theta/gamma frequency bands via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training
Measured: 12 weeks
Comparison of Phase Locking Value via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training
Measured: 12 weeks
Comparison of theta/gamma Phase-amplitude Coupling in auditory cortical areas via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training
Measured: 12 weeks
correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index.
Measured: 12 weeks
correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index.
Measured: 12 weeks
correlation between theta/gamma phase-amplitude coupling via EEG measurements of brain oscillatory activity during training and the language progression index.
Measured: 12 weeks
correlation between theta/gamma power via EEG measurements of brain oscillatory activity during training and the language progression index.
Measured: 12 weeks
correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index
Measured: 24 weeks
correlation between theta/gamma power via EEG measurements of brain oscillatory activity during training and the language progression index.
Measured: 24 weeks
correlation between theta/gamma phase-amplitude coupling via EEG measurements of brain oscillatory activity during training and the language progression index.
Measured: 24 weeks
correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IHU reConnect
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303413
- Sponsor's protocol ID
- 2024-091_THETABOOST
- Other IDs
- 2025-A00707-42
- Acronym
- THETABOOST
- Status last verified
- Dec 2025
- First submitted
- 11 Jun 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approche Rythmique et Auditive Chez Les Enfants Avec Troubles du Spectre de l'Autisme (TSA)
- ClinicalTrials.gov ID
- NCT07303413
- Acronym / sponsor ID
- THETABOOST / 2024-091_THETABOOST
- Conditions
- Autism Spectrum Disorder
- Keywords
- language
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- IHU reConnect
- Study start
- Jan 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Dec 2025 (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.
The aim of this study is to assess the effectiveness of a rhythmic auditory training program in improving language skills in children with Autism Spectrum Disorder (ASD) who have a language acquisition disorder. The program focuses on training children to reproduce the syllable rhythms of speech, and the study will evaluate the children's language skills before and after participating in the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| short baseline | Experimental | Behavioral: EEG recording, Behavioral: Picture recognition testFirst baseline of 4 weeks and a second baseline of 8 weeks |
| medium baseline | Experimental | Behavioral: EEG recording, Behavioral: Picture recognition testFirst baseline of 6 weeks and a second baseline of 6 weeks |
| long baseline | Experimental | Behavioral: EEG recording, Behavioral: Picture recognition testFirst baseline of 8 weeks and a second baseline of 4 weeks |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- aged between 3 and 6 at the time of inclusion
- Have received a formal medical diagnosis of ASD
- Have the consent of the parent(s)
- Declaration of a language delay by the parents
- Affiliated to social security or equivalent scheme
Key exclusion criteria (3 listed)
- Conditions likely to interfere with the EEG and make its interpretation difficult, including severe epilepsy or cerebral malformations.
- Treatments likely to interfere with the EEG (sedatives, psychostimulants, anxiolytics, antidepressants).
- Known hearing impairment
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 |
|---|---|---|
| EEG recordingEEG recording while listening to natural sounds | Behavioural | long baseline, medium baseline, short baseline |
| Picture recognition testChildren will have 4 images in front of them and a sound recording will be played to tell them which image to choose. They will have to click on the one that corresponds to what was said in the sound recording. | Behavioural | long baseline, medium baseline, short baseline |
Primary outcome
The difference in the progression of language acquisition measured by the difference in the number of images recognised in image recognition tests.
Time frame: 12 weeks
12 secondary outcomes
Comparison of Neural tracking of speech via EEG measurements of brain oscillatory activity before and after a session of listening to rhythmic sound.
Time frame: 12 weeks
Comparison of theta/gamma frequency bands via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training
Time frame: 12 weeks
Comparison of Phase Locking Value via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training
Time frame: 12 weeks
Comparison of theta/gamma Phase-amplitude Coupling in auditory cortical areas via EEG measurements of cerebral oscillatory activity before and after rhythmic auditory training
Time frame: 12 weeks
correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index.
Time frame: 12 weeks
correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index.
Time frame: 12 weeks
correlation between theta/gamma phase-amplitude coupling via EEG measurements of brain oscillatory activity during training and the language progression index.
Time frame: 12 weeks
correlation between theta/gamma power via EEG measurements of brain oscillatory activity during training and the language progression index.
Time frame: 12 weeks
correlation between Neural tracking via EEG measurements of brain oscillatory activity during training and the language progression index
Time frame: 24 weeks
correlation between theta/gamma power via EEG measurements of brain oscillatory activity during training and the language progression index.
Time frame: 24 weeks
correlation between theta/gamma phase-amplitude coupling via EEG measurements of brain oscillatory activity during training and the language progression index.
Time frame: 24 weeks
correlation between Phase Locking Value via EEG measurements of brain oscillatory activity during training and the language progression index.
Time frame: 24 weeks
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 24 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EEG recording and Picture recognition test in people with Autism Spectrum Disorder, run by Institut Pasteur.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The difference in the progression of language acquisition measured by the difference in the number of images recognised in image recognition tests. (time frame: 12 weeks). 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 24 Dec 2025.