Williams SyndromeSOUNDSNCT07285720
Phonological Constraints on Language Development in Individuals With Williams Syndrome
A study testing EEG-NIRS protocol and Questionnaire in people with Williams Syndrome and Language, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Williams syndrome (WS) is a neurodevelopmental disease characterized by mild to moderate intellectual disability and an extremely heterogeneous cognitive profile. Research has outlined two main features of WS: an atypical social behavior associated with surprising language abilities, and a hyperacusis. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Williams Syndrome, Language, Phonological Short-Term Memory
- What is being tested?
- EEG-NIRS protocol and Questionnaire
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jul 2024to Jul 2026
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- For SW and SD: genetic diagnosis and aged between 6- and 17 years old.
- For typical participants: any child, adolescent or young adult of the same developmental or chronological age (between 6 and 17 years of age)
- adult group (between 20 and 60 years).
Who cannot join
- Autistic Associated Disorders,
- West syndrome
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, 03 22 08 77 77, wallois.fabrice@chu-amiens.fr
About this study
Williams syndrome (WS) is a neurodevelopmental disease characterized by mild to moderate intellectual disability and an extremely heterogeneous cognitive profile. Research has outlined two main features of WS: an atypical social behavior associated with surprising language abilities, and a hyperacusis. The purpose of this project is to investigate the relationships between both these abilities, and particularly the role of the hyperacusis on language abilities. The hyperacusis would be crucial in developing language skills: the apparent strength in the verbal domain could rely on Phonological Short Term Memory (PSTM) more in individuals with WS than in typically developing individuals. In addition, the investigators will compare individuals with WS to individuals with Down syndrome (DS): DS is often associated to strong limitations in the PSTM with poor language abilities. To this end, the investigators will use a highly innovative approach including physiological assessments (EEG-NIRS protocol) and questionnaires. The performance of people with WS will be compared to those of participants with DS and TD participants of same DA and cognitive assessments.
- Conditions
- Williams Syndrome, Language, Phonological Short-Term Memory, EEG-NIRS
- Being tested
- EEG-NIRS protocol, Questionnaire
- Keywords
- Williams syndrome, Language, Phonological Short-Term Memory, EEG-NIRS
- Medical subject headings
- Williams Syndrome, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG-NIRS protocolOther
Each participant will be tested individually in a quiet room at the GRAMFC (Groupe de Recherches sur l'Analyse Multimodale de la Fonction Cérébrale, INSERM-UMR1105, Université Picardie Jules Verne and CHU Amiens-Picardie). Duration of subject's participation in the study is 120 minutes
QuestionnaireOther
Each participant will be tested individually in a quiet room at the GRAMFC (Groupe de Recherches sur l'Analyse Multimodale de la Fonction Cérébrale, INSERM-UMR1105, Université Picardie Jules Verne and CHU Amiens-Picardie). Duration of subject's participation in the study is 120 minutes
| Study group | Role | What they receive |
|---|---|---|
| Patients with Williams syndrome | Experimental | Not described Receives: Other: EEG-NIRS protocol; Other: Questionnaire |
| Patients with Down syndrome | Active comparator | Not described Receives: Other: EEG-NIRS protocol; Other: Questionnaire |
| Healthy children | Sham comparator | Not described Receives: Other: EEG-NIRS protocol; Other: Questionnaire |
| Healthy adults | Active comparator | Not described Receives: Other: EEG-NIRS protocol; Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
questionnaire score of patients with WS caracterisation
questionnaire score for cognitive profile of patients with WS caracterisation
Measured: 2 years
Secondary outcomes (1)
Impact of hyperacusis on questionnaire score
Impact of hyperacusis on questionnaire score
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start5 Jul 2024
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Williams SyndromeStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 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
- NCT07285720
- Sponsor's protocol ID
- PI2022_843_0021
- Acronym
- SOUNDS
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 16 Dec 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phonological Constraints on Language Development in Individuals With Williams Syndrome
- ClinicalTrials.gov ID
- NCT07285720
- Acronym / sponsor ID
- SOUNDS / PI2022_843_0021
- Conditions
- Williams Syndrome, Language, Phonological Short-Term Memory, EEG-NIRS
- Keywords
- Williams syndrome, Language, Phonological Short-Term Memory, EEG-NIRS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 16 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.
Williams syndrome (WS) is a neurodevelopmental disease characterized by mild to moderate intellectual disability and an extremely heterogeneous cognitive profile. Research has outlined two main features of WS: an atypical social behavior associated with surprising language abilities, and a hyperacusis. The purpose of this project is to investigate the relationships between both these abilities, and particularly the role of the hyperacusis on language abilities. The hyperacusis would be crucial in developing language skills: the apparent strength in the verbal domain could rely on Phonological Short Term Memory (PSTM) more in individuals with WS than in typically developing individuals. In addition, the investigators will compare individuals with WS to individuals with Down syndrome (DS): DS is often associated to strong limitations in the PSTM with poor language abilities. To this end, the investigators will use a highly innovative approach including physiological assessments (EEG-NIRS protocol) and questionnaires. The performance of people with WS will be compared to those of participants with DS and TD participants of same DA and cognitive assessments.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with Williams syndrome | Experimental | Other: EEG-NIRS protocol, Other: Questionnaire |
| Patients with Down syndrome | Active comparator | Other: EEG-NIRS protocol, Other: Questionnaire |
| Healthy children | Sham comparator | Other: EEG-NIRS protocol, Other: Questionnaire |
| Healthy adults | Active comparator | Other: EEG-NIRS protocol, Other: Questionnaire |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- For SW and SD: genetic diagnosis and aged between 6- and 17 years old.
- For typical participants: any child, adolescent or young adult of the same developmental or chronological age (between 6 and 17 years of age)
- adult group (between 20 and 60 years).
Key exclusion criteria (2 listed)
- Autistic Associated Disorders,
- West syndrome
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-NIRS protocolEach participant will be tested individually in a quiet room at the GRAMFC (Groupe de Recherches sur l'Analyse Multimodale de la Fonction Cérébrale, INSERM-UMR1105, Université Picardie Jules Verne and CHU Amiens-Picardie). Duration of subject's participation in the study is 120 minutes | Other | Healthy adults, Healthy children, Patients with Down syndrome, Patients with Williams syndrome |
| QuestionnaireEach participant will be tested individually in a quiet room at the GRAMFC (Groupe de Recherches sur l'Analyse Multimodale de la Fonction Cérébrale, INSERM-UMR1105, Université Picardie Jules Verne and CHU Amiens-Picardie). Duration of subject's participation in the study is 120 minutes | Other | Healthy adults, Healthy children, Patients with Down syndrome, Patients with Williams syndrome |
Primary outcome
questionnaire score of patients with WS caracterisation
Time frame: 2 years
questionnaire score for cognitive profile of patients with WS caracterisation
1 secondary outcome
Impact of hyperacusis on questionnaire score
Time frame: 2 years
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 16 Dec 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-NIRS protocol and Questionnaire in people with Williams Syndrome and Language, 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 2 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 16 Dec 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. Some participants in this study may receive a placebo. 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 (33+3 22 08 77 75, 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?
questionnaire score of patients with WS caracterisation (time frame: 2 years). 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 16 Dec 2025.