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Developmental Language DisorderNCT07899671

Learning in Children With Developmental Language Disorder

A study testing priming in people with Developmental Language Disorder, run by MGH Institute of Health Professions.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Developmental language disorder (DLD) is a condition that affects children's ability to learn and use language. These difficulties can affect communication, learning, and participation in everyday activities. Read more about this study

Who is it for?
Ages 5 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Developmental Language Disorder
What is being tested?
priming
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
No sites listed yet
Study dates
1 Dec 2026to 1 Sep 2031
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 5 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Age 5-6 years
  • English is the primary language spoken at home.
  • Pass a bilateral hearing screening
  • score within the typical range on a standardized nonverbal IQ measure
  • Standard scores greater than 85 on the Clinical Evaluation of Language Fundamentals-Fifth Edition (CELF-5).
  • Nonverbal IQ Index score on the Kaufman Brief Intelligence test, second edition (K-BIT 2) >75
Show all 12Show fewer
  • Age 5-6 years
  • English is the primary language spoken at home.
  • Pass a bilateral hearing screening
  • CELF-5 Core Language Composite score below 85 with below-average performance in at least two language domains, as indicated by CELF-5 index scores
  • Developmental history and parent-reported language concerns.
  • Nonverbal IQ Index score on the Kaufman Brief Intelligence test, second edition (K-BIT 2) >75

Who cannot join

  • Reported history of a delay in language development and no known or suspected neurodevelopmental, neurological, or learning disorders.
  • High risk for Dyslexia as indicated by a standard/scaled score at least 2 SD below the mean on all three measures of Rapid Naming, Phonological Awareness, and Letter Identification
  • Children with Developmental Language Disorder (DLD)
  • Known neurological deficits or diagnosis (e.g., Autism, TBI)
  • High risk for Dyslexia as indicated by a standard/scaled score at least 2 SD below the mean on all three measures of Rapid Naming, Phonological Awareness, and Letter Identification

About this study

Official title: Between Neural Entrainment and Learning in Children With Developmental Language Disorder

Developmental language disorder (DLD) is a condition that affects children's ability to learn and use language. These difficulties can affect communication, learning, and participation in everyday activities. Although DLD is relatively common, we still do not fully understand the brain processes that contribute to these language learning difficulties. A better understanding of these processes could help researchers identify children who may benefit from support earlier and develop new approaches to improve language learning.

One possible explanation for the language learning difficulties experienced by children with DLD is that they have difficulty identifying patterns in the speech they hear. To understand speech, children must learn to recognize where words begin and end, which sounds and words tend to occur together, and how words combine to form meaningful sentences. Children can learn many of these patterns simply by listening to language, even without being explicitly taught the rules. It is possible that difficulties in detecting and learning these patterns may contribute to the language challenges experienced by children with DLD.

Read more

This project focuses on a brain process called neural entrainment. Neural entrainment occurs when the brain's electrical activity synchronizes with patterns in the information we receive from the environment. For example, when we listen to speech, our brain activity can align with the rhythms and timing of the sounds. This synchronization may help the brain organize incoming information and identify important patterns that support learning. Previous research has linked neural entrainment to learning, and early findings suggest that children with DLD may show differences in how their brain activity synchronizes with speech. However, we do not yet know whether these differences are related to their learning difficulties or whether influencing these brain rhythms could help them learn better.

The proposed study will investigate these questions in 160 children, ages 5 to 6, with and without DLD. We will measure children's brain activity using electroencephalography (EEG), a safe, noninvasive method that records electrical activity through sensors placed on the scalp. The study will focus on a relatively slow brain rhythm known as the delta frequency band. This rhythm is of particular interest because previous research suggests that it may play a role in processing the timing and structure of speech.

The first goal is to determine whether children's brain rhythms are related to how well they learn different aspects of language. Children will participate in two learning activities. In the first activity, they will listen to a continuous stream of speech containing made-up words. The words will not be separated by pauses, so children will need to use patterns in the speech to figure out which sounds belong together and where the words begin and end. In the second activity, children will learn language through a more naturalistic task involving short stories and pictures. They will listen to sentences made up of unfamiliar words while viewing pictures that illustrate the stories. The sentences will follow a consistent structure, with an actor performing an action on another person or object. Together, these activities will allow us to investigate whether neural entrainment is associated with learning at both the word and sentence levels.

The second goal is to determine whether rhythmic sound stimulation can influence brain rhythms and learning. Before each learning activity, children will hear one of two types of sound sequences. One condition will involve rhythmic stimulation designed to match the slow timing of the delta frequency band. The other will serve as a comparison condition without the same regular rhythm. Each child will experience both conditions across two study sessions. We will compare children's learning between the two conditions to determine whether rhythmic stimulation improves their ability to identify words and learn sentence patterns. They will also examine whether any learning benefits are associated with changes in neural entrainment.

If neural entrainment is found to be consistently associated with children's ability to learn language patterns, it may eventually help researchers develop an objective measure to support the early identification of DLD. If rhythmic stimulation also improves learning, it could provide a foundation for developing new approaches to support language development. These applications will require further research, but the proposed study represents an important step toward understanding the brain mechanisms involved in learning and identifying new ways to support children who experience language difficulties.

Being tested
priming
Medical subject headings
Language Development Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • primingBehavioural

    Before each learning activity, children will hear one of two types of sound sequences. One condition will involve rhythmic stimulation designed to match the slow timing of the delta frequency band. The other will serve as a comparison condition without the same regular rhythm. Each child will experience both conditions across two study sessions.

Study groups in NCT07899671
Study groupRoleWhat they receive
PrimingExperimentalAll participants will complete the learning paradigms under two conditions, a rhythmic priming condition and a nonrhythmic control condition.
Receives: Behavioral: priming

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inter-trial coherence (ITC) to 1.8 Hz

    Inter-trial Coherence (ITC) is a measure of the strength of oscillatory phase-locking across trials. ITC values range from 1, reflecting completely phase-locked activity, to 0, indicating activity that is completely phase random with respect to the event of interest.

    Measured: At Visits 2 and 3 (up to approximately 4 weeks after Visit 1)

  2. Word segmentation Score (triplet learning paradigm)

    Reaction Time Ratio: The difference in mean reaction time between the first and final syllable, divided by mean reaction time for the first syllable.

    Measured: At Visits 2 and 3 (up to approximately 4 weeks after Visit 1)

  3. Word Learning Index (WLI) score (triplet learning paradigm)

    The ratio of Inter-Trial Coherence (ITC) of the delta range to Inter-trial Coherence (ITC) of the theta range.

    Measured: At Visits 2 and 3 (up to approximately 4 weeks after Visit 1)

  4. Word Knowledge Accuracy (sentence learning paradigm)

    Accuracy: % correct, evaluated across 18 trials.

    Measured: At Visits 2 and 3 (up to approximately 4 weeks after Visit 1)

  5. Sentence knowledge Accuracy (sentence learning paradigm)

    Accuracy: % correct, evaluated across 18 trials.

    Measured: At Visits 2 and 3 (up to approximately 4 weeks after Visit 1)

  6. D Prime (Grammatical Discrimination)

    d prime (d'), evaluated across 18 trials. d'=0 indicates no distinction between the signal and noise. Hit rate matches false alarm rate. d'>0: the higher the value, the stronger the distinction between signal and noise. d'<0: the more negative, indicate that false alarm rate is greater than hit rate.

    Measured: At Visits 2 and 3 (up to approximately 4 weeks after Visit 1)

Secondary outcomes (1)
  1. Inter-trial coherence (ITC) to 5.4 Hz

    In electroencephalogram (EEG) analysis inter-trial coherence measures how consistently the phase of a specific brain wave frequency aligns across trials. (possible range is 0-1; 0 is no phase alignment; 1 is perfect phase alignment). The closer the ITC value to 1, the stronger the alignment.

    Measured: At Visits 2 and 3 (up to approximately 4 weeks after Visit 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2026
  2. Study start1 Dec 2026 (estimated)
  3. Primary completion1 Jun 2031 (estimated)
  4. Study completion1 Sep 2031 (estimated)

Resources

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
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07899671
Sponsor's protocol ID
2026P002837
Other IDs
1R01DC023918-01A1
Status last verified
Oct 2026
First submitted
14 Oct 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing priming in people with Developmental Language Disorder, run by MGH Institute of Health Professions.

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 12 inclusion and 5 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 27 Oct 2026. 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?

Inter-trial coherence (ITC) to 1.8 Hz (time frame: At Visits 2 and 3 (up to approximately 4 weeks after Visit 1)). 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 27 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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